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    Summary
    EudraCT Number:2015-002077-37
    Sponsor's Protocol Code Number:SP-ECT
    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:2021-09-09
    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 number2015-002077-37
    A.3Full title of the trial
    PHASE II STUDY OF INTRAOPERATIVE ELECTROCHEMOTHERAPY IN PATIENTS WITH UNRESECTABLE PANCREATIC CANCER
    STUDIO DI FASE II DELLA ELETTROCHEMIOTERAPIA INTRAOPERATORIA IN PAZIENTI CON TUMORE DEL PANCREAS NON RESECABILE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY ON SAFETY AND FEASIBILITY OF ELECTROCHEMOTHERAPY USED IN OPERATORY ROOM FOR A PATIENT WITH CANCER PANCREAS NOT OPERABLE
    STUDIO SULLA SICUREZZA E LA FATTIBILITA' DELL'ELETTROCHEMIOTERAPIA UTILIZZATA IN SALA OPERATORIA SU UN PAZIENTE CON UN TUMORE AL PANCREAS NON OPERABILE
    A.3.2Name or abbreviated title of the trial where available
    SP-ECT
    SP-ECT
    A.4.1Sponsor's protocol code numberSP-ECT
    A.5.4Other Identifiers
    Name:SP- ECTNumber:SP- ECT
    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 OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    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 supportIGEA S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    B.5.2Functional name of contact pointsupporto no profit
    B.5.3 Address:
    B.5.3.1Street AddressP.le A. Stefani
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37126
    B.5.3.4CountryItaly
    B.5.4Telephone number045-8127043
    B.5.5Fax number045-8122814
    B.5.6E-mailsupporto.noprofit@oaovr.veneto.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 BLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS 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.3.4Pharmaceutical form Suspension for injection
    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 INNBLEOMICINA SOLFATO
    D.3.9.1CAS number 11056-06-7
    D.3.9.2Current sponsor code039269016
    D.3.9.3Other descriptive nameBleocin sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Patient suffering from exocrine or neuroendocrine, non-metastatic and inoperable pancreatic cancer, stage III
    Paziente affetto da tumore al pancreas esocrino o neuroendocrino non operabile e senza metastasi, stadio III
    E.1.1.1Medical condition in easily understood language
    pancreatic cancer
    tumore al pancreas non operabile
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033600
    E.1.2Term Pancreatic adenocarcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety assessment of the impact of ECT associated with bleomycin
    Valutazione dell’impatto della ECT con Bleomicina sulla sicurezza
    E.2.2Secondary objectives of the trial
    1. feasibility assessment of the applied technique
    2. ECT quality life assessment
    3. ECT treatment response evaluation
    4. Overall Survival assessment at 18 months
    1. Valutazione della fattibilità della tecnica utilizzata
    2. Valutazione dell’impatto della ECT sulla qualità di vita
    3. Valutazione della risposta al trattamento ECT
    4. Valutazione della sopravvivenza globale a 18mesi (Overall Survival)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female and Male, Ege =18 =80 anni. Women will' perform pregnacy test before surgery and during follow up visit.
    2. Consent form signed
    3. Patient that could done follow up (18 months)
    4. Diagnosis of pancreatic cancer, confirmed by histological test.
    5. Stage III
    6. Patient colud not be trated with “gold-standard” (surgery)
    7. Stable Disease
    1. Maschi e Femmine di età compresa tra i 18 e 80 anni. I soggetti femminili in età fertile secondo linee guida CTFG eseguiranno, in regime di ricovero nei giorni immediatamente precedenti l’intervento, un test di gravidanza che dovrà risultare negativo. Inoltre tutti i soggetti dovranno essere d’accordo nell’utilizzare un efficace metodo contraccettivo per i 12 mesi successivi dalla data dell’intervento
    2. Capacità di firmare un consenso informato specifico al fine di essere
    ammesso allo studio.
    3. Aspettativa di vita atta a seguire il follow up di 18 mesi indicato dallo
    studio
    4. Diagnosi di cancro pancreatico esocrino, o neuroendocrino con
    conferma istologica.
    5. Staging Pre-operativo della malattia di cancro pancreatico localmente
    avanzato: stage III
    6. Il soggetto non è eleggibile per il trattamento “gold-standard” di
    pancreatectomia chirurgica
    7. Malattia stabile (non metastasi, non aumento dimensionale del tumore
    primitivo) alla diagnostica per immagini dopo tre mesi di chemioterapia
    neoadiuvante
    E.4Principal exclusion criteria
    1. Age =18 =80
    2. pregnant
    3. Patient that not accepted to use contraceptive methods
    4. Patient that coul not done surgery
    5. Patient with disease not stable
    6. Patient with liver , lung and /or peritoneal.
    7. Patient that take phenytoin , fosphenytoin , live vaccines
    1. Paziente con meno di 18 anni o più di 80
    2. Donne in gravidanza o a rischio di gravidanza e in allattamento
    3. Pazienti che non accettano di utilizzare metodi contraccettivi per i dodici mesi successivi alla data dell’intervento.
    4.Controindicazione assoluta alla chirurgia a cielo aperto
    5.Pazienti con malattia in rapida evoluzione (sottostadiati al momento della diagnosi) o con
    comportamento biologico aggressivo che già dopo tre mesi svilupperanno progressione locale
    sistemica di malattia, la percentuale di questi pazienti e del 14% circa.
    6. Il soggetto ha metastasi epatiche, polmonari e/o peritoneali.
    7. Pazienti che assumono fenitoina, fosfenitoina, vaccini vivi
    E.5 End points
    E.5.1Primary end point(s)
    1) monitoring adverse events according to CTCAE criteria during the 18 months of follow up 2) monitoring clinical paramenters (T° C, blood pressure, heart rate), laboratory parameters (specific tumor markers CEA and Ca19.9 and inflammation index PCR) and instrumental parameters (eventually normal clinical practice exams) during the 18 months of follow up
    1) rilevazione degli eventi avversi secondo CTCAE (Comnon Terminolgy Criteria of adverse events) 2) monitoraggio dei parametri clinici ( T°C, Pressione Arteriosa, Frequenza Cardiaca), laboratoristici (markers tumorali specifici CEA e Ca19.9 e indice di infiammazione PCR) e strumentali (ndagini radiologiche eventualmente prescritte secondo normale pratica clinica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months of follow up
    18 mesi di follow up
    E.5.2Secondary end point(s)
    1) feasibility assessment of the applied technique understood as perfectly successful operation (bleomycin injection and proper and possible insertion of electrodes in the time and manner prescribed by the protocol) 2) for the Quality Life assessment it will use the Karnofsky Performance Index 13.12 each follow-up visit (to 1.3.6.9.12.15.18 months after ECT) and VAS to the different time points (to 1.3.6.9.12.15.18 months after ECT) 3) for ECT treatment response evaluation it will used RECIST criteria to 1.3.6.9.12 months after ECT 4) Overall Survival measurement at 12th month after ECT, measured as time from ECT to death because of all causes5) adaptive and innate immune response will be evaluated by the variation in levels of IL6 and HSP70 between the pre-ECT, 2 days and 30 days after surgery.
    1) valutazione della fattibilità tecnica intesa come numero di casi in cui l’intervento riesce perfettamente (iniezione bleomicina e corretto e possibile inserimento degli elettrodi nei tempi e modi stabiliti dal protocollo) 2) per la valutazione della qualità della vita verrà utilizzata la Karnofsky Perfomance Index 12.13 ad ogni visita di follow up (a 1.3.6.9.12.15.18 mesi dalla ECT) e la VAS ai diversi timepoint (1.3.6.9.12.15.18 mesi dalla ECT) 3) per la valutazione della risposta al trattamento ECT con Bleomicina verrà utilizzata la valutazione secondo criteri RECIST a 1 e 3, 6,9, 12 mesi dalla ECT 4) la stima della sopravvivenza globale misurata al follow up del mese 18 misurata come tempo dalla ECT alla morte per tutte le cause. 5) la risposta immuniaria adattiva e innata sarà valutata mediante la variazione dei livelli di IL6 e HSP70 tra il pre-ECT, a 2 giorni e a 30 giorni dall'intervento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 mesi di follow up
    18 mesi di follow up
    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.8.5.1Number of sites anticipated in the EEA1
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 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)
    NA
    NA
    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 Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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