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    Summary
    EudraCT Number:2016-005129-35
    Sponsor's Protocol Code Number:FENET-2016
    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 number2016-005129-35
    A.3Full title of the trial
    "Peptide Receptor Radionuclide Therapy (PRRT) with somatostatin analogs in tumors over-expressing somatostatin receptors"
    ¿Terapia radiorecettoriale con analoghi radiomarcati della somatostatina in tumori con elevata espressione dei recettori per la somatostatina¿
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nuclear Medicine therapy using synthetic somatostatin analogues that are radiolabelled with high-energy beta(-) emitting isotopes, for the treatment of tumors overexpressing somatostatin specific receptors (on the surface of the cell membrane) enable to bind and internalize the radiolabelled analogues mentioned above
    Terapia medico nucleare che impiega analoghi sintetici della somatostatina radiomarcati con isotopi beta(-) emettitori ad alta energia, per la cura di neoplasie che esprimono (in grande quantit¿) sulla superficie della membrana cellulare recettori specifici per la somatostatina in grado di legare e internalizzare i suddetti analoghi radiomarcati
    A.3.2Name or abbreviated title of the trial where available
    PRRT in tumours over-expressing somatostatin receptors
    PRRT in tumori esprimenti recettori della somatostatina
    A.4.1Sponsor's protocol code numberFENET-2016
    A.5.4Other Identifiers
    Name:NDNumber:NA
    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 DI FERRARA
    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 di Ferrara
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Ferrara
    B.5.2Functional name of contact pointS.C. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressVia A. Moro, 8
    B.5.3.2Town/ cityCona-Ferrara
    B.5.3.3Post code44124
    B.5.3.4CountryItaly
    B.5.4Telephone number0532 236082
    B.5.5Fax number0532 236359
    B.5.6E-mailm.bartolomei@ospfe.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 No
    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 name90Y-DOTATOC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN90Y-Edotreotide
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13
    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) Yes
    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) 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 Yes
    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.IMP: 2
    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 No
    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 name177Lu-DOTATOC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN177Lu-Edotreotide
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number18 to 27
    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) Yes
    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 Yes
    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
    Tumors over-expressing somatostatin receptors
    Neoplasie esprimenti recettori per la somatostatina
    E.1.1.1Medical condition in easily understood language
    Tumors over-expressing somatostatin receptors
    Neoplasie esprimenti recettori per la somatostatina
    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 HLT
    E.1.2Classification code 10014712
    E.1.2Term Endocrine neoplasms malignant and unspecified NEC
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of the study will be to evaluate the disease control rate (partial response, complete response, disease stability for at least 12 months from the beginning of treatment) of patients subjected to PRRT.
    L¿obiettivo primario dello studio sar¿ di valutare il controllo di malattia (risposta parziale, risposta completa, stabilit¿ di malattia per almeno 12 mesi dall¿inizio del trattamento) dei pazienti sottoposti a PRRT.
    E.2.2Secondary objectives of the trial
    The secondary aims will be:
    ¿ To assess the safety profile of PRRT (acute and late toxicity), especially as regards critical organs (renal parenchyma and bone marrow);
    ¿ To evaluate progression-free survival time (PFS) and overall survival time (OS);
    ¿ to correlate the response to PRRT with the degree of histological differentiation at the time of diagnosis and the stage of disease at the time of enrollment in this clinical study;
    ¿ To correlate, basing on dosimetric evaluation, the activity and toxicity of treatment, respectively, with the dose to the tumour and the critical organs;
    ¿ To analyse any changes in the quality of life (QOL) by the detection of subjective parameters according to the EORTC QLQ-C30 scheme;
    ¿ To evaluate the predictive value of PET-TC with 18f-FDG on PFS and OS.
    Gli obiettivi secondari saranno:
    ¿ valutare il profilo di sicurezza della PRRT (tossicit¿ acuta e tardiva), soprattutto per quel che riguarda gli organi critici (parenchima renale e midollo osseo);
    ¿ valutare il tempo di sopravvivenza libera da progressione (PFS) e il tempo di sopravvivenza globale (OS);
    ¿ correlare la risposta alla PRRT con il grado di differenziazione istologica al momento della diagnosi e lo stadio di malattia al momento dell¿arruolamento nel presente studio clinico;
    ¿ correlare, sulla base delle valutazioni dosimetriche, l¿attivit¿ e la tossicit¿ del trattamento rispettivamente con la dose al tumore e agli organi critici;
    ¿ analizzare le eventuali modificazioni della qualit¿ della vita (QoL) attraverso la rilevazione dei parametri soggettivi secondo lo schema EORTC QLQ-C30;
    ¿ valutare il valore predittivo della PET-TC con 18F-FDG sulla PFS e sulla OS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age = 18 years, of both sexes, of any ethnicity;
    2. Hhistological and immunohistochemical diagnosis of NET;
    3. Evaluation of the cell proliferation index by study of Ki-67 and/or MIB-1.
    4. Disease measurable according to the RECIST 1.1 criteria by conventional imaging (TC with MDC or MRI with MDC) not before the two months of enlistment;
    5. High expression of somatostatin receptors documented by PET-TC with 68Ga-DOTATOC in the target lesion (s). It is defined as "high expression of the receptors for Somatostatin" a report of SUVmax lesion/SUVmean muscle = 4:1 calculated with semi-quantitative analysis at the PET-TC examination with 68Ga-dotatoc;
    6. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrolment;
    7. Evaluation of glucose metabolism in the target lesion (s) by PET-TC with 18F-FDG;
    8. Conserved haematological, hepatic and renal parameters, in particular:
    -White blood cells = 2500/µl
    -platelets = 90000/µl
    -hemoglobin = 9 gr/dl
    -creatinine = 2 mg/dl
    -bilirubin = 2.5 mg/dl
    9. ECOG performance status = 2;
    10. Life expectancy = 6 months;
    11. Stable or progressive disease, at any stage, in both operable and non-operable patients;
    12. Absence of standard treatments already documented and of equal efficacy;
    13. No surgical treatment, chemotherapy and/or radiation for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biological drugs (e.g. m-tor inhibitors) may be considered to be enrolled;
    14. Voluntary accession to the study by signing the informed consent form, after reading and complete understanding of the information notes.
    1. Età =18 anni, di ambo i sessi, di qualunque etnia;
    2. Diagnosi cito-istologica ed immunoistochimica di NET;
    3. Valutazione dell’indice di proliferazione cellulare mediante studio di Ki-67 e/o MIB-1.
    4. Malattia misurabile secondo i criteri RECIST 1.1 mediante imaging convenzionale (TC con mdc o RMN con mdc) non antecedente ai due mesi rispetto all’arruolamento;
    5. Elevata espressione di recettori per la somatostatina documentata mediante PET-TC con 68Ga-DOTATOC nella/e lesione/i target. Si definisce come “elevata espressione dei recettori per la somatostatina” un rapporto di SUVmax lesione/SUVmean muscolo = 4:1 calcolato con analisi semi-quantitativa all’esame PET-TC con 68Ga-DOTATOC;
    6. Dosaggio della Cromogranina A (e di eventuali altri markers specifici) non antecedente ai due mesi rispetto all’arruolamento;
    7. Valutazione del metabolismo glucidico nella/e lesione/i target mediante PET-TC con 18F-FDG;
    8. Parametri ematologici, epatici e renali conservati, in particolare:
    - globuli bianchi =2500/µL
    - piastrine = 90000/µL
    - emoglobina = 9 gr/dL
    - creatinina = 2 mg/dL
    - bilirubina = 2.5 mg/dL
    9. ECOG performance status =2;
    10. Aspettativa di vita = 6 mesi;
    11. Malattia stabile o in progressione, in qualunque stadio, sia in pazienti operati che non operabili;
    12. Assenza di trattamenti standard già documentati e di pari efficacia;
    13. Assenza di trattamenti chirurgici, chemioterapici e/o radioterapici da almeno 30 giorni. Di contro, potranno essere presi in considerazione per l’arruolamento i pazienti in terapia con analoghi della somatostatina o farmaci biologici (per esempio: inibitori di m-TOR);
    14. Adesione volontaria allo studio tramite firma del modulo di consenso informato, dopo lettura e completa comprensione delle note informative.
    E.4Principal exclusion criteria
    1. Lack of the requirements listed above;
    2. Pregnancy status;
    3. Breastfeeding and its refusal to suspend breastfeeding;
    4. Participation in another therapeutic experimental clinical protocol in the four weeks preceding PRRT;
    5. Ensured medullary disease invasion > 25%;
    6. Extended Radiation treatments (emibody).
    1. Mancanza dei requisiti sopra elencati;
    2. Stato di gravidanza;
    3. Allattamento e relativo rifiuto di sospendere l’allattamento;
    4. Partecipazione ad un altro protocollo clinico sperimentale terapeutico nelle quattro settimane precedenti la PRRT;
    5. Accertata invasione midollare di malattia >25%;
    6. Pregressi estesi trattamenti radioterapici (emibody).
    E.5 End points
    E.5.1Primary end point(s)
    The "intent-to-treat (ITT)" population is the population of all patients enrolled to participate in this protocol. The activity population (AP) is represented by all ITT patients except those who, although recruited during the preliminary phase, will not undergo-for any reason-the actual therapeutic treatment. The AP coincides, in this study, with the safety population (SP) and includes all patients who have received at least one therapy cycle. Primary endpoint analysis Each patient will be categorized into one of the following categories: 1) Complete response 2) Partial response 3) Disease stability for at least 12 months from the beginning of treatment 4) Disease progression 5) Early death by tumour 6) Early death for toxicity 7) Early death for other causes 9) not assessable for insufficient data. Patients in categories 1, 2, 3 will be treated as under disease control. Patients in categories 4, 5, 6, 7, 8, 9 will be considered as failures of therapy.
    La popolazione “intention-to-treat (ITT)” è la popolazione di tutti i pazienti arruolati per partecipare al presente protocollo. L’activity population (AP) è rappresentata da tutti i pazienti dell’ITT eccetto quelli che, benché reclutati durante la fase preliminare, non si sottoporranno - per qualsiasi motivo – all’effettivo trattamento terapeutico. L’AP coincide, nel presente studio, con la safety population (SP) e include tutti i pazienti che hanno ricevuto almeno un ciclo di terapia. Analisi dell’endpoint primario Ogni paziente verrà classificato in una delle seguenti categorie: 1) risposta completa 2) risposta parziale 3) stabilità di malattia per almeno 12 mesi dall’inizio del trattamento 4) progressione di malattia 5) morte precoce per tumore 6) morte precoce per tossicità 7) morte precoce per altre cause 9) non valutabile per dati insufficienti. I pazienti nelle categorie 1,2,3 verranno considerati come sotto controllo di malattia. I pazienti nelle categorie 4,5,6,7,8,9 verranno considerati come fallimenti della terapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis will be carried out one year after the start of the enlistment to assess the activity of treatment, toxicity and compliance with the Protocol and subsequent analysis after the end of the study.
    Si prevede un’analisi ad interim da eseguirsi a un anno dall’inizio dell’arruolamento per valutare l’attività del trattamento, la tossicità e la compliance al protocollo e successive analisi dopo la fine dello studio.
    E.5.2Secondary end point(s)
    PFS and OS will be evaluated by the Kaplan-Meier method (Kaplan El, Meier P., J am Stat Assoc 1958); The analysis will be performed on the AP population. Dose estimates for the tumour and renal parenchyma may be correlated with disease control, PFS, OS, QOL and with acute and late toxicity to the renal parenchyma by uni-multivariate analysis. All adverse events will be recorded and encoded according to the CTC-AE version 4.0 criteria in the safety population.
    PFS e OS verranno valutati con il metodo di Kaplan-Meier (Kaplan El, Meier P., J Am Stat Assoc 1958); l¿analisi verr¿ eseguita sulla AP population. Le stime della dose al tumore e al parenchima renale potranno essere correlate rispettivamente con il controllo di malattia, PFS, OS, QoL e con la tossicit¿ acuta e tardiva a carico del parenchima renale mediante analisi uni-multivariata. Tutti gli eventi avversi verranno registrati e codificati secondo i criteri CTC-AE versione 4.0 nella safety population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    An interim analysis will be carried out one year after the start of the enlistment to assess the activity of treatment, toxicity and compliance with the Protocol and subsequent analysis after the end of the study.
    Si prevede un¿analisi ad interim da eseguirsi a un anno dall¿inizio dell¿arruolamento per valutare l¿attivit¿ del trattamento, la tossicit¿ e la compliance al protocollo e successive analisi dopo la fine dello studio.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Early and delayed clinical, laboratory, instrumental evaluations, as specified in the protocol
    Visite cliniche ed esami di laboratorio e strumentali a breve e lungo termine, come specificato nel protocollo
    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 Decision2018-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-29
    P. End of Trial
    P.End of Trial StatusOngoing
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