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    Summary
    EudraCT Number:2017-004675-31
    Sponsor's Protocol Code Number:AMCmedonc17-010
    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:2021-06-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004675-31
    A.3Full title of the trial
    A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
    Uno studio randomizzato di Fase II sul trattamento di seconda linea con irinotecan liposomiale e S1 rispetto a irinotecan liposomiale e 5-fluorouracile in pazienti con carcinoma pancreatico metastatico che non hanno ottenuto risultati con la chemioterapia di prima linea a base di gemcitabina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of treatment with liposomal and S1 irinotecan versus liposomal and 5-fluorouracil irinotecan in patients with metastatic pancreatic cancer who did not achieve results with gemcitabine first-line chemotherapy
    Studio di fase II sul trattamento con irinotecan liposomiale e S1 rispetto a irinotecan liposomiale e 5-fluorouracile in pazienti con carcinoma del pancreas metastatico che non hanno ottenuto risultati con la chemioterapia di prima linea a base di gemcitabina
    A.3.2Name or abbreviated title of the trial where available
    NAPAN study
    NAPAN Study
    A.4.1Sponsor's protocol code numberAMCmedonc17-010
    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 SponsorACADEMIC MEDICAL CENTRE AMSTERDAM
    B.1.3.4CountryNetherlands
    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 supportUniversity of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointEva van Daalen
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205668229
    B.5.5Fax number+31205668229
    B.5.6E-mailtrialmedonc@amc.nl
    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 Pegilato Liposomiale
    D.2.1.1.2Name of the Marketing Authorisation holderLes laboratoires Servier
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOnivyde Liposomiale Pegilato
    D.3.2Product code [EMA/515476/2016]
    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 INNirinotecan anhydrous free base
    D.3.9.1CAS number 97682-44-5
    D.3.9.2Current sponsor codeOnivyde Liposomiale Pegilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number60
    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 Teysuno
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Group BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTeysuno, S-1
    D.3.2Product code [EMA/20503/2012]
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtegafur, gimeracil e oteracil
    D.3.9.1CAS number 150863-82-4
    D.3.9.2Current sponsor codeS-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    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 RoleComparator
    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 Sodio Levofolinato medac 50 mg/ml soluzione iniettabile o per infusione
    D.2.1.1.2Name of the Marketing Authorisation holderMEDAC
    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 nameSodio levofolinato
    D.3.2Product code [V03 AF 10]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNacido folinico
    D.3.9.1CAS number 58-05-9
    D.3.9.2Current sponsor codeSodio levofolinato
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 RoleComparator
    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.3.2Product code [15859]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-FLUOROURACILE
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-FLUOROURACILE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2400
    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
    pancreatic cancer
    carcinoma pancreatico metastatico
    E.1.1.1Medical condition in easily understood language
    advanced pancreatic cancer
    tumore al pancreas in stadio avanzato
    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 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    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
    Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose
    (MTD) of nal-IRI when co-administered with fixed dose S1 in patients
    with metastatic pancreatic cancer.
    Phase II part: Efficacy between the treatment arms in terms of
    progression free survival.
    Fase di Run-in: Dose limite di tossicità (DLT) e dose massima tollerata (MTD) di nal-IRI in caso di co-somministrazione con dose fissa S1 in pazienti con carcinoma pancreatico metastatico.
    Parte II: efficacia tra i bracci di trattamento in termini di sopravvivenza libera da progressione.
    E.2.2Secondary objectives of the trial
    Overall survival
    Response rate according to RECIST 1.1
    Adverse events according to NCI CTC version 4.0
    Quality of life
    Sopravvivenza globale
    Tasso di risposta secondo RECIST 1.1
    Eventi avversi secondo NCI CTC versione 4.0
    Qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    = 18 years of age
    Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
    Documented metastatic disease
    Previously treated with gemcitabine or gemcitabine containing therapy,
    or progression within 6 months of adjuvant gemcitabine treatment
    Adequate hepatic, renal and hematological function
    Caucasian
    Età = 18 anni
    Adenocarcinoma istologicamente o citologicamente confermato del pancreas esocrino
    Malattia metastatica documentata
    Precedentemente trattati con gemcitabina o gemcitabina contenente terapia,
    o progressione entro 6 mesi dal trattamento adiuvante con gemcitabina
    Funzione epatica, renale ed ematologica adeguata
    caucasico
    E.4Principal exclusion criteria
    KPS < 70
    Any clinically significant gastrointestinal disorder, including hepaticdisorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
    Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
    NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically
    significant abnormal findings
    Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's
    health
    Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
    Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
    Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
    History of severe and unexpected reactions to fluoropyrimidine therapy
    Known dihydropyrimidine dehydrogenase (DPD) deficiency
    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 liposomal irinotecan (nal-IRI).
    Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine
    KPS <70
    Qualsiasi disturbo gastrointestinale clinicamente significativo, inclusi disturbi epatici, sanguinamento, infiammazione, occlusione o diarrea> grado 2
    Gravi eventi tromboembolici arteriosi (infarto del miocardio, angina pectoris instabile, ictus) negli ultimi 6 mesi
    Insufficienza cardiaca congestizia di classe III o IV NYHA, aritmie ventricolari o pressione sanguigna incontrollata. O noto ECG anormale con risultati anormali clinicamente significativi
    Infezione attiva o febbre inspiegabile> 38,5 ° C (esclusa la febbre del tumore), che secondo il medico potrebbe compromettere la salute del paziente
    Uso corrente o qualsiasi uso nelle ultime due settimane di forti induttori / inibitori dell'enzima CYP3A e / o potenti inibitori dell'UGT1A
    Ipersensibilità nota a uno qualsiasi dei componenti dell'irinotecan liposomiale (nal-IRI) altre formulazioni liposomiali di irinotecan, irinotecan, fluoropirimidine o leucovorin.
    Ipersensibilità a uno qualsiasi dei principi attivi (tegafur, gimeracil e oteracil)
    Storia di reazioni gravi e inattese alla terapia con fluoropirimidina
    Deficit nota di diidropirimidina deidrogenasi (DPD)
    Allattamento al seno, gravidanza nota, test di gravidanza sierico positivo o riluttanza a utilizzare un metodo affidabile di controllo delle nascite, durante la terapia e per 3 mesi dopo l'ultima dose di irinotecan liposomiale (nal-IRI).
    Trattamento entro 4 settimane con inibitori della DPD, inclusa la sorivudina o i suoi analoghi chimicamente correlati come la brivudina
    E.5 End points
    E.5.1Primary end point(s)
    Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer.
    Phase II part: Efficacy between the treatment arms in terms of progression free survival.
    Fase di run-in: dose limite di tossicità (DLT) e dose massima tollerata (MTD) di nal-IRI in caso di co-somministrazione con dose fissa S1 in pazienti con carcinoma pancreatico metastatico.
    Parte II: efficacia tra i bracci di trattamento in termini di sopravvivenza libera da progressione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation with CTscan/ MRI will take place every 2 months
    Valutazione con CTscan / MRI che avrà luogo ogni 2 mesi
    E.5.2Secondary end point(s)
    Quality of life; Response rate according to RECIST 1.1; Adverse events according to NCI CTC version 4.0; Overall survival
    Qualità della vita; Tasso di risposta secondo RECIST 1.1; Eventi avversi secondo NCI CTC versione 4.0; Sopravvivenza globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quality of life will be evaluated every 2 months; Evaluation with CTscan/ MRI will take place every 2 months; Adverse events will be evaluated every 2 weeks; Evaluation with CTscan/ MRI will take place every 2 months
    La qualità della vita sarà valutata ogni 2 mesi; La valutazione con CTscan / MRI avrà luogo ogni 2 mesi; Gli eventi avversi saranno valutati ogni 2 settimane; La valutazione con CTscan / MRI avrà luogo ogni 2 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Yes
    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 years3
    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 years3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Follow up for late toxicity every 8 weeks and report date of death
    Monitorare la tossicità tardiva ogni 8 settimane e riportare la data di morte
    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 Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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