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    Summary
    EudraCT Number:2017-000345-46
    Sponsor's Protocol Code Number:CRC2017_01
    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 number2017-000345-46
    A.3Full title of the trial
    A Phase II Study of Liposomial IrinoTecan (nal-IRI) with 5-Fluorouracil, Levofolinic Acid and Oxaliplatin in Patients With Resectable Pancreatic Cancer ¿nITRo trial"
    Studio di fase II con Irinotecan Liposomiale (nal-IRI), 5
    Fluorouracile, Acido levofolinico e Oxaliplatino in pazienti con carcinoma pancreatico resecabile ¿studio nITRo¿
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with anti cancer drugs in patients with resectable parcreatic cancer ¿nITRo trial"
    Studio con farmaci anti tumorali in pazienti con tumore del pancreas resecabile ¿studio nITRo¿
    A.3.2Name or abbreviated title of the trial where available
    nITRo trial
    studio nITRo
    A.4.1Sponsor's protocol code numberCRC2017_01
    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 SponsorCENTRO RICERCHE CLINICHE DI 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 supportBaxalta GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Ricerche Cliniche di Verona
    B.5.2Functional name of contact pointCentro Ricerche Cliniche di Verona
    B.5.3 Address:
    B.5.3.1Street AddressP.le L.A. Scuro, 10
    B.5.3.2Town/ cityVerona (VR)
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.4Telephone number0458126618
    B.5.5Fax number0458126669
    B.5.6E-mailstefano.milleri@crc.vr.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 ONIVYDE
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/933
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.2.1.1.1Trade name OXALIPLATINO ACCORD - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 40 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE 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.3.1Product nameoxaliplatino
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA 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.3.1Product name5-fluorouracile
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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: 4
    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 LEDERFOLIN - 100 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO
    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.3.1Product namelederfolin
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Resectable pancreatic cancer
    Tumore pancreatico resecabile
    E.1.1.1Medical condition in easily understood language
    Resectable pancreatic cancer
    tumore del pancreas resecabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033602
    E.1.2Term Pancreatic adenocarcinoma resectable
    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 purpose of this study is to determine the proportion of patients with resectable pancreatic cancer achieving macroscopically complete tumor removal with negative microscopic surgical margins (R0) resection after preoperative nanoliposomal irinotecan (nal-IRI), Oxaliplatin, Leucovorin (LV), 5-FluoroUracil (5-FU)
    Lo scopo di questo studio ¿ quello di determinare la percentuale di pazienti con tumore pancreatico resecabile che sono riusciti ad ottenere una rimozione completa del tumore visibile con un margine chirurgico microscopico negativo, dopo la terapia preoperatoria con Irinotecan liposomiale (nal-IRI), Oxaliplatino, acido levofolinico, 5-fluorouracile (5-FU)
    E.2.2Secondary objectives of the trial
    To determine 2-year OS in patients treated with multimodality approach combining perioperative chemotherapy with surgery.
    To determine DFS from the time of resection in patients treated with multimodality approach combining perioperative chemotherapy with surgery.
    To estimate frequency and severity of adverse events associated with chemotherapy.
    To determine ORR following preoperative chemotherapy.
    To estimate proportion of patients going to surgery for resection after preoperative chemotherapy.
    To estimate pCR after R0 or macroscopically complete tumor removal with any positive microscopic surgical margin (R1) resection.
    To assess lymph node status.
    To correlate pre-operative response of CA19-9 with DFS and OS.
    To assess surgical mortality and morbidity.
    Determinare OS in pazienti trattati con approccio multimodale, combinando chemioterapia perioperatoria ed intervento chirurgico.
    Determinare DFS dal momento della resezione, in pazienti trattati con approccio multimodale, combinando chemioterapia perioperatoria ed intervento chirurgico.
    Determinare la frequenza e la gravit¿ degli eventi avversi associati alla chemioterapia.
    Determinare ORR successivamente a chemioterapia preoperatoria.
    Stimare una quota di pazienti destinati all¿intervento chirurgico per la resezione del tumore dopo il trattamento di chemioterapia preoperatoria.
    Stimare pCR, dopo R0 o la rimozione completa del tumore visibile e di ogni margine chirurgico microscopico (R1).
    Valutare lo stato dei linfonodi.
    Correlare la risposta preoperatoria del CA19-9 con DFS e OS.
    Valutare la mortalit¿ chirurgica e la morbosit¿.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and provide written informed consent.
    2. = 18 years of age.
    3. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
    4. Adequate hepatic, renal and hematological function.
    5. Patients must have measurable disease in the pancreas, with no evidence of metastatic disease on imaging of the chest, abdomen and pelvis (contrast-enhanced CT or MRI abdomen with contrast instead of abdominal CT); PET scans alone will not be adequate alternatives.
    6. The primary tumor must be surgically resectable, defined as:
    a. no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or superior mesenteric artery);
    b. no involvement or <180° interface between tumor and vessel wall of the portal vein, superior mesenteric vein and/or portal vein/splenic vein confluence.
    1. Essere capaci di intendere ed in grado di firmare il consenso informato .
    2. = 18 anni di età.
    3. Conferma istologica o citologica di adenocarcinoma del pancreas esocrino.
    4. Adeguata funzionalità epatica, renale ed ematologica.
    5. I pazienti devono avere una massa misurabile nel pancreas, con nessuna evidenza a livello radiologico di metastasi nel torace, nell addome, e nelle pelvi (TAC con metodo di contrasto o Risonanza magnetica all’ addome con contrasto al posto di TAC addominale); la sola PET non sarà considerata un alternativa valida.
    6. Il tumore primario deve essere asportabile chirurgicamente, il che significa:
    a. Nessun coinvolgimento (abutment o encasement) delle arterie maggiori (celiaca, epatica commune e/o arteria mesenterica superiore);
    b. Nessun coinvolgimento o interfaccia < 180° tra il tumore e la parete della vena porta, vena mesenterica superiore e/o alla confluenza fra la vena porta e la vena splenica.
    E.4Principal exclusion criteria
    1. Serum total bilirubin =2 x ULN (biliary drainage is allowed for biliary obstruction).
    2. Severe renal impairment (CLcr = 30 ml/min).
    3. Inadequate bone marrow reserves as evidenced by:
    4. ANC = 1,500 cells/µl; or Platelet count = 100,000 cells/µl; or Hemoglobin = 9 g/dL
    5. KPS < 60
    6. Patients who received previous chemotherapy or radiotherapy for pancreatic disease.
    7. Any clinically significant disorder impacting the risk-benefit balance negatively per physician’s judgment.
    8. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2.
    9. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months.
    10. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings.
    11. Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health.
    12. Known hypersensitivity to any of the components of nanoliposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
    13. Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
    14. Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study ¿
    15. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results ¿
    16. Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of nanoliposomal irinotecan (nal-IRI). Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 3 months after last application of program treatment. A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs.
    1. Bilirubina totale nel siero =2 x ULN (il drenaggio biliare é permesso in caso di ostruzione biliare).
    2. Grave insufficienza renale (CLcr = 30 ml/min).
    3. Inadeguatezza delle riserve di midollo osseo, evidenziate da:
    4. ANC = 1,500 cellule/µl; o Conteggio delle piastrine = 100,000 cellule/µl; o Emoglobina= 9 g/dL
    5. KPS < 60
    6. Pazienti che sono stati precedentemente sottoposti a chemioterapia o radioterapia per tumore al pancreas.
    7. Qualsiasi disordine significativo dal punto di vista clinico, che possa avere impatto negativo sull’ equilibrio rischio –beneficio secondo il parere del medico.
    8. Qualsiasi disordine gastrointestinale clinicamente significativo, inclusi: disordini epatici, emorragie, infiammazioni, occluisioni o diarrea di grado > a 2.
    9. Gravi eventi di tromboembolia arteriosa (infarto del miocardio, angina pectoris instabile, infarto) negli ultimi 6 mesi.
    10. NYHA di classe III o IV, insufficenza cardiaca congestiva, aritmia ventricolare o pressione sanguigna non sotto controllo. ECG fuori dalla norma con risultati anormali clinicamente significativi.
    11. Infezioni in atto o febbre di natura sconosciuta > 38.5 °C (escludendo la febbre tumorale) che secondo l ‘ opinione del medico potrebbe compromettere la salute del paziente.
    12. Ipersensibilità nota ad uno qualsiasi dei componenti del Irinotecan Liposomiale (nal-IRI) ad altre formulazioni contenenti Irinotecan Liposomiale, Irinotecan, fluoropyrimidines, or leucovorin.
    13. Utilizzo corrente o nelle ultime due settimane di forti induttori/ inibitori dell enzima CYP3A e /o forti inibitori del UGT1A.
    14. Somministrazione di una terapia sperimentale entro 4 settimane, o in un intervallo di tempo inferiore (almeno 5 emivite) dell’agente in studio, precedentemente alla prima somministrazione programmata per questo studio.
    15. Qualsiasi altra condizione medica o sociale che l’investigatore ritenga possa interferire con la capacità del paziente di firmare il consenso informato, cooperare e partecipare allo studio, o possa interferire con l’interpretazione dei risultati. ¿
    16. Allattamento, gravidanza, test di gravidanza su siero positivo o riluttanza ad utilizzare un affidabile mezzo di contraccezione, durante la terapia e per tre mesi dopo l’ultima dose di Irinotecan Liposomiale (nal-IRI). Le donne in età fertile devono accettare l’utilizzo e l‘assunzione di metodi contraccettivi efficaci (Indice di Pearl < 1) oppure l’astinenza totale da rapporti eterosessuali durante tutta la durata dello studio e per minimo 3 mesi dall’ultima somministrazione programmata del trattamento. Una donna é considerata in età fertile a meno che non abbia un età = 50 anni , non sia naturalmente amenorroica da = 2 anni o sterile chirurgicamente. Gli Uomini devono accettare di non concepire un figlio ( compresa la donazione di sperma) durante tutta la durata dello studio e per almeno 6 mesi dall’ ultima somministrazione del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients achieving R0 resection, defined accordingly to the International Study Group of Pancreatic Surgery guidelines as a resection margin >1 mm. Tumour clearance should be given for all of the following margins: anterior, posterior, medial, or superior mesenteric groove, SMA, pancreatic transection, bile duct, and enteric. Surgery will be performed after receiving 3 cycles of chemotherapy preoperatively planned at up to 12 weeks. It will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.
    Numero di pazienti che raggiungono una resezione R0, definite in accord all’ International Study Group of Pancreatic Surgery guidelines, come una resezione con margine >1 mm. L’assenza di tumore dovra’ essere valutata per i seguenti margini: anteriore, posteriore, mediale o superior, mesenterico, SMA, a livello della resezione pancreatica, dotto biliare, ed enterico. L’intervento chirurgico sara’ eseguito dopo aver ricevuto 3 cicli di chemioterapia pianificati in 12 settimana.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    OS from enrollment to death from any cause. ; DFS from randomization to recurrence (loco-regional or distant) or death due to any cause.; Incidence of toxicities greater than grade 4, using Common Terminology Criteria for Adverse Events version 4.0.; ORR after neoadjuvant chemotherapy with RECIST 1.1.; Overall resection rate.; Number of partecipants achieving pCR.; Lymph node status; Biochemical response rate by Ca 19.9 decrease; Number of partecipants experiencing perioperative mortality or morbidity
    OS dall¿arruolamento al decesso per qualsiasi causa.; DFS dall¿arruolamento alla recidiva (locale o a distanza) o morte per qualsiasi causa.; Incidenza di tossicita¿ di grado superiore a 4, utilizzando Common Terminology Criteria for Adverse Events version 4.0.; ORR valutata con RECIST 1.1. dopo chemioterapia adiuvante.; Percentuale di soggetti resecati.; Numero di partecipanti che raggiungono pCR.; Stato dei linfonodi ; Percentuale di risposta biochimica misurata dalla diminuzione di Ca 19.9; Numero di partecipanti con mortalita¿ o morbilita¿ nel periodo perioperativo
    E.5.2.1Timepoint(s) of evaluation of this end point
    time frame up to 2 years; time frame up to 2 years.; time frame every two weeks during treatment; time frame up to 2 year; time frame immediately after surgery; time frame up to 2 years; time frame immediately after surgery; time frame after 3 months of induction therapy; time frame up to 30 days from surgery
    nei successive 2 anni.; nei successive 2 anni.; ogni 2 settimane durante il trattamento; nei successivi 2 anni; immediatamente dopo l'intervento chirurgico; nei successivi 2 anni; immediatamente dopo l'intervento chirurgico; dopo 3 mesi di terapia; fino a 30 giorni dopo l'intervento chirurgico
    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
    collecting information on death or survival after 2 years from the last dose of the last subject (LDLS)
    raccolta delle informazioni sul decesso o sopravvivenza a 2 anni dopo l'ultima dose dell' ultimo soggetto (LDLS)
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 67
    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)
    standard care by the oncological medical department
    saranno presi in carico dall'UOC di oncologia medica
    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 Decision2017-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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