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    Summary
    EudraCT Number:2022-003787-24
    Sponsor's Protocol Code Number:PM-CARE-PNRR-MAD-2022-12375905
    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:2023-01-31
    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 number2022-003787-24
    A.3Full title of the trial
    Precision Medicine in patients with unresectable CholAngiocarcinoma; RadioEmbolization and combined biological therapy
    (Single arm, multicenter phase II study investigating the efficacy and safety of a novel therapeutic scheme in patients with unresectable CholAngiocarcinoma; RadioEmbolization in combination with CisGem and Durvalumab)
    Protocolli terapeutici di medicina di precisione in pazienti con colangiocarcinoma non resecabile: radioembolizzazione con CisGem e durvalumab
    (Studio clinico, multicentrico di fase II sulla efficacia e sicurezza di un o schema terapeutico innovativo in pazienti con colangiocarcinoma non resecabile: Radioembolizzazione in combinazione con cisplatino - gemcitabina e durvalumab)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Precision Medicine in patients with unresectable Cholangiocarcinoma; RadioEmbolization and combined biological therapy
    Medicina di precisione in pazienti con Cholangicarcinoma non resecabile; Radioembolizzazione con CisGem e durvalumab
    A.3.2Name or abbreviated title of the trial where available
    PM-CARE
    PM-CARE
    A.4.1Sponsor's protocol code numberPM-CARE-PNRR-MAD-2022-12375905
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportBando PNRR 2022
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAleph
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia Cucchiari, 9
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20155
    B.5.3.4CountryItaly
    B.5.4Telephone number0240707107
    B.5.5Fax number02700541273
    B.5.6E-mailinfo@alephsrl.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.2.1.2Country 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 nameGemcitabina
    D.3.2Product code [NA]
    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 INNGEMCITABINA
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 Yes
    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 nameCisplatino
    D.3.2Product code [NA]
    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 INNCISPLATINO
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    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 IMFINZI - 50 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 10 ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    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 nameIMFINZI - durvalumab
    D.3.2Product code [MEDl4736]
    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 INNDURVALUMAB
    D.3.9.1CAS number 1428953-60-7
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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
    Unresectable intrahepatic cholangiocarcinoma
    Colangiocarcinoma intraepatico non resecabile
    E.1.1.1Medical condition in easily understood language
    Cholangiocarcionoma - bile duct cancer - that forms in the bile ducts inside the liver and that cannot be surgically removed.
    Colangiocarcinoma - tumore delle vie biliari - che si sviluppa nelle cellule dei dotti biliari all'interno del fegato e che non è operabile.
    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 LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess efficacy-defined as overall response rate - of radioembolization (TARE) followed by a combination of standard of care chemotherapy with cisplatin and gemcitabine plus durvalumab in patients with liver predominant unresectable intrahepatic cholangiocarcinoma and assess the safety of the therapeutic scheme. This study will administer durvalumab out of its current indication (indication for first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) approved by the FDA on September 2, 202; positive opinion given by EMA's Committee for Medicinal Products for Human Use (CHMP) for the same indication awaiting European Commission Approval). Radioembolization will be performed using SIR-Spheres® resin Microspheres (loaded with yttrium-90 ) code SIR-Y001; an approved class II medical device device (145685IR) outside its indication for use for which a request to initiate an investigation will be sent to the Ministry of Health.
    Valutare l'efficacia-definita come overall response rate-dell'associazione di trattamento locoregionale-radioembolizzazione (TARE) seguito da trattamento sistemico i.e. combinazione di cisplatino e gemcitabina con durvalumab e valutarne la sicurezza. ll durvalumab sarà somministrato fuori dalla sua corrente indicazione (indicazione dell'uso del durvalumab in associazione con cisplatino e gemcitabina come trattamento di prima linea in pazienti con tumori delle vie biliari non resecabili o metastatici approvata dal FDA il 2 settembre 2022;parere positivo del Committee for Medicinal Products for Human Use(CHMP) EMA il 10 novembre 2022 per la stessa indicazione (attesa approvazione Comm. Europea). La radioembolizzazione avverrà tramite l'utilizzo di microsfere in resina SIR-Spheres® caricate con ittrio-90 codice codice SIR-Y001; dispositivo medico (145685IR) al di fuori della sua corrente indicazione per l'uso per la quale verra inviata richiesta di avvio indagine al Ministero della Salute
    E.2.2Secondary objectives of the trial
    Describe tumor biological aspects; Investigate the relationship between tumor circulating markers, tumor tissue based markers,quantitative non-invasive imaging and radiomics-based parameters,
    genetic markers in tissue and biological substrates; Evaluate tumor mutational burden, immunological landscape in responders and non-responders to treatment at given time points and among time points; Quantitative imaging based parameters in responders and non-responders at given time points and among time points; Interim assessment of efficacy of treatment regimen.
    Descrivere gli aspetti biologici tumorali; Valutare la relazione tra marcatori circolanti tumorali, marcatori tumorali tessutali, parametri quantitativi non-invasivi di imaging inclusi la radiomica; marcatori genetici tissutali e in substrati biologici; valutare il tasso mutazionale del tumore, microambiente in termini immunologico nei "responder" e "non responder" al trattamento ai vari tempi e tra i diversi tempi di valutazione; Parametri di imaging quantitativi nei "responder" e "non responder" al trattamento ai vari tempi e tra i diversi tempi di valutazione; valutazione interim dell'efficacia dei regimi di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Suspected or biopsy-confirmed diagnosis of intrahepatic cholangiocarcinoma (ICC), not previously treated with systemic or surgical therapies;
    - Preserved liver function, defined as: Child Pugh Class A; MELD score (Model forEnd Stage Liver Disease Score} <10;
    - No technical contraindication to TARE, confirmed by pre-procedural angiography and scintigraphy;
    - Hepatitis B virus (HBV} DNA test and Hepatitis C virus (HCV} RNA test negative at screening;
    - Adequate heart and lung function;
    - ECOG Performance Score O or 1;
    - Adequate renal and hepatic function, as indicated by: serum creatinine <2x the upper limit of normal and estimated glomerular filtration rate (eGFR) >30ml/min or 1.73m/2; alkaline phosphatase (ALP}, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST} s 5 times the upper limit of normal (ULN) and total bilirubin s 2.0 mg/dl;
    - Hemoglobin greater than or equal to10 g/dL, platelet count greater than or equal to 70,000/mm3, absolute neutrophil count >1500/mm3.
    - Ability and willingness to provide written informed consent and to comply with study protocol and procedures
    - Sospetto o diagnosi confermata da biopsia di colangiocarcinoma intraepatico (ICC), non precedentemente trattato con terapie sistemiche o chirurgiche;
    - Funzione epatica conservata, definita come: Classe A di Child Pugh; punteggio MELD (Model for End Stage Liver Disease Score} <10;
    - Nessuna controindicazione tecnica alla TARE, confermata dall'angiografia e dalla scintigrafia pre­ procedurali;
    - Test per ii virus dell'epatite B (HBV} e test dell'RNA per ii virus dell'epatite C (HCV} negativi allo screening;
    - Funzionalità cardiaca e polmonare adeguata;
    - ECOG Performance Score O o 1;
    - Funzionalità renale ed epatica adeguata, come indicate da: creatinina sierica <2x ii limite superiore della norma e velocità di filtrazione glomerulare stimata (eGFR) >30ml/min o 1,73m2; fosfatasi alcalina (ALP}, alanina aminotransferasi (ALT) e/o aspartato aminotransferasi (AST} s 5 volte ii limite superiore della norma (ULN) e bilirubina totale s 2,0 mg/dl;
    - Emoglobina maggiore o uguale a 10 g/dL, conta piastrinica maggiore o uguale a 70.000/mm3, conta assoluta dei neutrofili > 1500/mm3.
    - Capace e disponibile a fornire ii consenso informato scritto e a rispettare ii protocollo e le procedure dello studio
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding women;
    - Uncorrectable coagulopathies
    - Extensive disease extrahepatic or extrarenal
    - Tumor classified as combined or mixed type (HCC and ICC} at screening
    - Child-Pugh Class B or higher or evidence of severe portal hypertension at screening or at any time up to and including baseline;
    - History of major gastrointestinal bleeding requiring medical attention within 30 days prior to screening or at baseline;
    - Known hypersensitivity to the specific chemotherapy agents used during the study;
    - Any oral or parenteral chemotherapy or immunotherapy treatment within 2 years prior to screening;
    - Previous allogeneic bone marrow transplant, kidney or legacy transplant;
    - Active viral, bacterial or fungal infections, clinically relevant to the assessment of fitness;
    - Current history or evidence of neuropsychiatric illness, including depression, schizophrenia, bipolar disorder, impaired cognition, dementia, or suicidal tendencies;
    - History of serious cardiovascular disease, such as a previous stroke, coronary artery disease requiring surgery, or unresolved arrhythmias within the last 6 months.
    - Evidence of any hematologic malignancy;
    - Positive to human immunodeficiency virus type 1 or 2 (HIV-1, HIV-2) (serum or RNA} and/or hepatitis B virus surface antigen (HBsAg} and/or active infection with Treponema Pallidum or Mycoplasma;
    - Abuse of alcohol in the 2 months prior to the study or abuse of any substance in the 6 months prior to the study;
    - Known bleeding diathesis or history of abnormal bleeding or any other known coagulation abnormality that may contraindicate future surgery or biopsies;
    - Use of immunosuppressant steroids (prednisone equivalent > 10 mg/day};
    - Presence of hepatopulmonary shunt >20% or other contraindications to arterial radioembolization
    - Donne in gravidanza o in allattamento;
    -Coagulopatie non corregibili
    -Malattia estesa in sede extraepatica o extrarenale- Tumore classificato ccme tipo combinato o misto (HCC e ICC} allo screening;
    -Classe Child-Pugh B o superiore o evidenza di ipertensione portale grave allo screening o in qualsiasi momenta fino al basale incluso;
    -Storia di emorragia gastrointestinale importante che ha richiesto un intervento medico nei 30 giorni precedenti lo screening o al basale;
    - lpersensibilità nota agli agenti chemioterapici specifici utilizzati durante lo studio;
    - Qualsiasi trattamento chemioterapicoo immunoterapico orale o parenterale nei 2 anni precedenti lo screening;
    • Precedente trapianto allogenico di midollo osseo, trapianto di rene o di legato;
    • lnfezioni virali, batteriche o fungine attive, clinicamente rilevanti per la valutazione dell'idoneita;
    • Anamnesi attuale o evidenza di malattie neuropsichiatriche, tra cui depressione, schizofrenia, disturbo bipolare, compromissione della funzione cognitiva, demenza o tendenza al suicidio;
    • Storia di gravi malattie cardiovascolari, come un precedente ictus, una malattia coronarica che richiede un intervento chirurgico o aritmie non risolte negli ultimi 6 mesi.
    • Evidenza di qualsiasi neoplasia ematologica;
    • positivita al virus dell'immunodeficienza umana di tipo 1 o 2 (HIV-1, HIV-2) (siero o RNA} e/o all'antigene di superficie del virus dell'epatite B (HBsAg} e/o infezione attiva da Treponema Pallidum o Mycoplasma;
    • Abuse di alcol nei 2 mesi precedenti lo studio o abuse di allre sostanze nei 6 mesi precedenti lo studio;
    • Diatesi emorragica nota o anamnesi di sanguinamento anomalo o qualsiasi altra anomalia della coagulazione nota che possa controindicare fuluri interventi chirurgici o biopsie;
    • Uso di immunosoppressorio steroidi (prednisone equivalente> 10 mg/die};
    • Presenza di shunt epatopolmonare >20% o altre controindicazioni alla radioembolizzazione arteriosa
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Overall response rate (ORR) according to mRECIST 1.1 criteria on imaging
    Safety: Evaluate adverse events, laboratory findings, vital signs and other diagnostic evaluation alterations
    Efficacia: risposta al trattamento definito come overall response rate (ORR) secondo i criteri mRECIST 1.1 su imaging
    Sicurezza: Valuatre eventi avversi, alterazioni delle varie valutazione diagnostiche (valori di laboratorio, segni vitali, tra le altre)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: at six (6) months after radioembolization (TARE).
    Safety: throughout the study
    Efficacia: a sei (6) mesi dalla radioembolizzazione (TARE)
    Sicurezza: durante tutto lo studio
    E.5.2Secondary end point(s)
    Describe tumor biological aspects: Investigate the relationship between tumor circulating markers, tumor tissue based markers; quantitative non-invasive imaging and radiomics-based parameters; genetic markers in tissue and biological substrates; Describe the tumor microenvironment (tissue and circulating biomarkers, quantitative imaging, immune response) correlate these with response to treatment; distinguish characteristics of responders vs non-responders;; Efficacy: interim evaluation of treatment response defined as overall response rate according to mRECIST 1.1 e RECIST
    Descrivere il microambiente tumorale: valutare la relazione tra i marcatori tumorali circolanti, marcatori tumorali tissutali; valutazione dei parametri quantitativi non invasivi estratti dall'imaging e dalla valutazione radiomica; marcatori genetici tissutali e valutazione dei substrati biologici; Descrivere il micro-ambiente tumorale (biomarcatori tessutali e circolanti, quantitativi su imaging, risposta immunitaria) e correlato con la risposta al trattamento; distinguere caratteristiche di responder vs i non responder;; Efficacia: valutazione ad interim della risposta al trattamento definita come overall response response rate secondo criteri mRECIST 1.1 e RECIST
    E.5.2.1Timepoint(s) of evaluation of this end point
    Serial blood sampling; cytokine profiling - baseline, at approximately one month ( pre-systemic treatment), at three months post TARE
    Biopsy prior to and following treatment - baseline and at three months post TARE
    Imaging: protocol defined imaging time points basal, at one month, three months, six months post TARE and at imaging time points during follow up; Data collected during the study; evaluation against imaging at 3 and 6 months - overall evaluation at the end of the treatment period; Imaging at three months after radioembolizzation (TARE)
    Valutazione su sangue periferico: al basale, a un mese circa (pre-trattamento sisemico) e e sei mesi post TARE
    Biopsia tessuto tumorale: al baslae e a tre mesi post TARE
    Imaging: alle tempistiche descritte da protocollo; basle, 1 mese, 3 mesi, 6 mesi post TARE e imaging al follow-up; Dati raccolti durante lo studio; valutazione effettuata 3 e 6 mesi dalla TARE - valutazione a fine studio; Imaging a tre (3) mesi dalla radioembolizzazione (TARE)
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    braccio singolo
    Single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nessun comparatore - studio a braccio singolo
    no comparator - single arm study
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 33
    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)
    Potentially continue with this regimen if approved at end-of-study time, if needed and feasible in case of partial response; continue with the systemic treatment proposed by each structure in case of disease recurrence; in the event of OS and reduction of the disease burden, define the other available therapeutic strategies in a multidisciplinary setting.
    Potenzialmente continuare con questo schema terapeutico se approvato al tempo di fine studio, se necessario e fattibile in caso di risposta parziale; continuare con ii trattamento sistemico proposto da ciascuna struttura in caso di recidiva di malattia; in caso di OS e di diminuzione del carico di malattia, definire in sede multidisciplinare le altre strategie terapeutiche disponibili.
    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 Decision2023-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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