Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002597-12
    Sponsor's Protocol Code Number:013-IRCC-10IIS-16
    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:2020-12-15
    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 number2016-002597-12
    A.3Full title of the trial
    A PHASE II TRIAL OF RECHALLENGE WITH PANITUMUMAB DRIVEN BY RAS CLONAL-MEDIATED DYNAMIC OF RESISTANCE. THE CHRONOS TRIAL.
    STUDIO DI FASE II CON PANITUMUMAB “RE-CHALLENGE” GUIDATA DALLA DINAMICA DELLA RESISTENZA CLONALE RAS-MEDIATA IN PAZIENTI CON CARCINOMA METASTATICO DEL COLON RETTO ORIGINARIAMENTE RESPONSIVI AD UN mAb ANTI-EGFR. STUDIO CHRONOS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY TO TEST PANITUMUMAB FOR THE TREATMENT OF THIRD LINE mCRC PATIENT SELECTED ON THE BASIS OF KRAS GENE MOLECULAR ANALYSIS. THE CHRONOS TRIAL.
    STUDIO DI FASE II CON PANITUMUMAB PER IL TRATTAMENTO DI TERZA LINEA DI PAZIENTI AFFETTI DA CARCINOMA METASTATICO DEL COLON RETTO SELEZIONATI SULLA BASE DELL'ANALISI MOLECOLARE DEL GENE KRAS.
    A.3.2Name or abbreviated title of the trial where available
    CHRONOS TRIAL
    STUDIO CHRONOS
    A.4.1Sponsor's protocol code number013-IRCC-10IIS-16
    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 SponsorFONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCCS
    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 supportAmgen Srl
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAIRC
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportFondazione Piemontese per la Ricerca sul Cancro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA
    B.5.2Functional name of contact pointCLINICAL RESEARCH OFFICE
    B.5.3 Address:
    B.5.3.1Street AddressSTRADA PROVINCIALE
    B.5.3.2Town/ cityCANDIOLO
    B.5.3.3Post code10060
    B.5.3.4CountryItaly
    B.5.4Telephone number0119933842
    B.5.5Fax number0119933825
    B.5.6E-mailcosimo.martino@ircc.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 VECTIBIX - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 20 ML
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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 namePANITUMUMAB
    D.3.2Product code [ABX-EGF]
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.2Current sponsor codeABX-EGF
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    METASTATIC COLORECTAL CANCER
    CARCINOMA METASTATICO DEL COLON RETTO
    E.1.1.1Medical condition in easily understood language
    LARGE INTESTINE TUMOR
    TUMORE DEL GROSSO INTESTINO
    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 10001172
    E.1.2Term Adenocarcinoma of colon stage IV
    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
    To evaluate the efficacy of a third-line Panitumumab re-challenge in patients with metastatic colorectal cancer (mCRC), originally responsive to anti EGFR therapy, selected on the basis of RAS extended clonal evolution in plasma.
    Valutare l'efficacia del rechallenge con Panitumumab nel carcinoma del colon-retto metastatico di tipo selvaggio RAS / RAF (mCRC), senza evidenza plasmatica di cloni potenzialmente resistenti che presentano mutazioni di RAS o EGFR-ectodominio.
    E.2.2Secondary objectives of the trial
    • To assess Progression Free Survival (PFS) and Overall Survival (OS) after panitumumab re-challenge.
    • To determine the safety and tolerability of panitumumab re-challenge.
    • Translational Objectives:
    1) To correlate the decay kinetics of RAS-extended clone(s) during anti-EGFR treatment holiday with response to panitumumab rechallenge.
    2) To link the blood-presence of RAS-extended clone(s) (if any) during panitumumab treatment with response and response duration.
    3) To describe by NGS the tumor ctDNA plasma landscape before and after panitumumab re-challenge.
    4) To determine potential associations, if existing, between different mutated ctDNA clones (RAS or others) and response to panitumumab re-challenge.
    • Determinare la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) dopo il re-challenge con panitumumab.
    • Determinare la sicurezza ed il profilo di tollerabilità della terapia di re-challenge con panitumumab.
    • Obiettivi Traslazionali:
    1) Correlare la cinetica di decadimento dei cloni RAS extended nel periodo di sospensione della terapia anti-EGFR con la risposta al panitumumab in terza linea (re-challenge).
    2) Correlare la presenza nel plasma di cloni RAS extended (se presenti) durante il trattamento con panitumumab con la risposta e la durata della risposta alla terapia.
    3) Descrivere attraverso l’analisi NGS il profilo molecolare del ctDNA nel plasma prima e dopo la terapia di re-challenge con panitumumab.
    4) Determinare potenziali associazioni, se presenti, tra i differenti cloni mutati riscontrati nel ctDNA (RAS o altri) e la risposta alla terapia di re-challenge con panitumumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of metastatic colorectal cancer;
    2. Age = 18 years;
    3. Written informed consent;
    4. Documented WT RAS exons 2, 3 and 4 (KRas and NRas) and WT BRAF V600E for anti-EGFR treatment.
    5. Complete or partial response to anti EGFR antibodies in any line either received as monotherapy or in combination with chemotherapy;
    6. Imaging documented progression while on therapy with a therapeutic regimen including anti-EGFR mAb;
    7. Imaging documented progression at the last treatment regimen that must be anti-EGFR free;
    8. Patient must be RAS and EGFR ectodomain wild type in a liquid biopsy performed no longer that 4 weeks after progression to the last anti-EGFR free treatment
    9. FFPE sample used for eligibility to anti-EGFR prescription (see criteria 4) must be available for custom gene panel profiling (as described in appendix B). Otherwise if sample is not available, center must have already perfomed a genotyping on this tissue sample according to appendix B.
    10. ECOG performance status = 2;
    11. At least one measurable tumor lesion as per RECIST v1.1. Lesions in previously irradiated areas or those that have received other loco-regional therapies (i.e. percutaneous ablation) should not be considered measurable unless there is clear documented evidence of progression of the lesion since therapy. Imaging must be performed maximum within 28 days prior to registration;
    12. Normal organ functions;
    13. Negative serum pregnancy test within 1 week prior to the first study dose in all women of childbearing potential;
    14. Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception;
    15. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    1. Conferma istologica della diagnosi di carcinoma metastatico del colon retto;
    2. Età = 18 anni;
    3. Firma del consenso informato;
    4. Certificazione dello stato WT dei geni RAS esoni 2, 3 and 4 (KRas e NRas) e dell’assenza della mutazione BRAF V600E;
    5. Risposta parziale o completa ad un regime di prima linea contenente un Ab anti-EGFR.
    6. Progressione documentata con immagini durante ad un regime terapeutico che include mAb anti-EGFR;
    7. Progressione documentata con immagini all’ultimo trattamento fatto con un chemioterapico.
    8. Il paziente deve risultare RAS ed EGFR wild type dall’analisi di una biopsia liquida eseguita non più di 4 settimane dalla progressione all'ultimo trattamento anti-EGFR libero
    9. Il blocchetto diagnostico del tumore deve essere disponibile per effettuare l’analisi del pannello genetico personalizzato come descritto nell’appendice B. Nel caso in cui blocchetto non sia disponibile, il centro deve aver già effettuato la genotipizzazione del tessuto come indicato nella appendice B.
    10. ECOG performance status = 2;
    11. Almeno una lesione misurabile secondo RECIST v1.1. Lesioni in aree precedentemente irradiate o che hanno ricevuto altre terapie loco-regionali (i.e. ablazioni percutanee) non dovrebbero essere considerate misurabili a meno che non ci sia una chiara evidenza documentata di progressione della lesione dopo la terapia. L’esame radiologico deve essere effettuato entro i 28 giorni precedenti alla registrazione nello studio;
    12. Funzione normale degli organi;
    13. Esito negativo di un test di gravidanza sierico effettuato entro 1 settimana prima dell’inizio della prima dose del farmaco in studio in tutte le donne potenzialmente fertili;
    14. Le pazienti in età fertile e i loro partner devono essere disposti a evitare la gravidanza durante la loro partecipazione allo studio. I soggetti di sesso maschile le cui partners siano ipotenzialmente fertili e i soggetti di sesso femminile potenzialmente fertili, pertanto, devono essere disposti ad utilizzare adeguati mezzi di contraccezione;
    15. Assenza di qualsiasi condizione psicologica, familiare, sociologica o geografica che possa potenzialmente ostacolare la partecipazione al protocollo e al follow up; tali condizioni dovrebbero essere discusse con il paziente prima della registrazione nello studio.
    E.4Principal exclusion criteria
    1. History of severe infusion reactions to monoclonal antibodies cetuximab or panitumumab;
    2. Symptomatic or untreated leptomeningeal disease and symptomatic brain metastasis;
    3. Clinically significant cardiac disease including:
    a. congestive heart failure requiring treatment (NYHA grade = 2), Left ventricular ejection fraction (LVEF) < 45% as determined by Multigated acquisition (MUGA) scan or echocardiogram;
    b. history or presence of clinically significant ventricular arrhythmias or atrial fibrillation;
    c. clinically significant resting bradycardia;
    d. unstable angina pectoris = 3 months prior to starting study drug;
    e. acute myocardial infarction = 3 months prior to starting study drug;
    f. QTcF > 480 msec;
    4. History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism;
    5. Patients with interstitial pneumonitis or pulmonary fibrosis;
    6. Abnormal organ or bone marrow functions defined as:
    a. Absolute neutrophil count < 1.5 x 10/L;
    b. hemoglobin < 9 g/dL;
    c. alkaline phosphatase > 2.5 x upper normal limit (ULN), if liver metastases > 5 x ULN;
    d. aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2.5 x ULN, if liver metastases > 5 x ULN;
    e. bilirubin > 1.5 x ULN, if liver metastases > 2 x ULN;
    f. serum creatinine > 1.5 x ULN and/or creatinine clearance = 50 mL/min calculated according to Cockroft-Gault;
    g. Patients with platelet count <100 x 10^9/L
    7. Previous or concurrent second malignancy. Exceptions: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively and without evidence of recurrence for at least 3 years prior to study entry.
    8.Patients with positive serology for HIV, HBV, HCV.
    9. Patients with a history of severe or life threatening hypersensitivity to the active substance or to any of the excipients.
    1. Storia di reazioni severe all’infusione degli anticorpi monoclonali cetuximab o panitumumab;
    2. Patologie leptomeningee sintomatiche o non trattate e metastasi cerebrali sintomatiche;
    3. Patologie cardiache clinicamente significative, incluso:
    a. insufficienza cardiaca congestizia che richiede trattamento (NYHA grado = 2), frazione di eiezione ventricolare sinistra (LVEF) <45%, come determinato dallo scan di acquisizioni multiple (MUGA) o ecocardiogramma;
    b. storia o presenza di aritmie ventricolari clinicamente significative o fibrillazione atriale;
    c. bradicardia a riposo clinicamente significativa;
    d. angina pectoris instabile = 3 mesi prima di iniziare il farmaco in studio;
    e. infarto acuto del miocardio = 3 mesi prima di iniziare il farmaco in studio;
    f. f. QTcF> 480 msec;
    4. Storia di eventi tromboembolici o cerebrovascolari negli ultimi 6 mesi, compreso attacco ischemico transitorio, ictus, trombosi venosa profonda, embolia polmonare;
    5. Pazienti con polmonite interstiziale o fibrosi polmonare;
    6. Anomalia d’organo o funzione del midollo osseo come segue:
    a. conta assoluta dei neutrofili <1,5 x 10/L;
    b. emoglobina <9 g/dl;
    c. fosfatasi alcalina >2,5 x limite superiore della norma (ULN), se metastasi epatiche >5 x ULN;
    d. aspartato aminotransferasi (AST)/alanina aminotransferasi (ALT)>2,5 x ULN, se metastasi epatiche >5 x ULN;
    e. bilirubina >1,5 x ULN, se metastasi epatiche >2 x ULN;
    f. creatinina sierica >1.5 x ULN e/o clearance della creatinina =50 ml/min calcolati secondo Cockroft-Gault.
    g. Pazienti con conta piastrinica < 100x10^9/L
    7. Secondo tumore primario precedente o concomitante. Eccezioni: carcinoma basocellulare o a cellule squamose della pelle, carcinoma in situ della cervice uterina trattato e senza evidenza di recidiva per almeno 3 anni precedenti all'arruolamento nello studio; altro tumore solido trattato e senza evidenza di recidiva per almeno 3 anni precedenti all'arruolamento nello studio.
    8. Pazienti con positività sierologica a HIV, HBV, HCV
    9. Pazienti con storia di ipersensività grave o potenzialmente letale nei confronti del farmaco sperimentale o dei suoi eccipienti
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) to panitumumab according to RECIST v1.1.
    Tasso di risposta obiettiva (ORR) al panitumumab secondo RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q8 WEEKS (+/- 3 DAYS)
    OGNI 8 SETTIMANE (+/- 3 GIORNI)
    E.5.2Secondary end point(s)
    PROGRESSION FREE SURVIVAL (PFS); OVERALL SURVIVAL (OS); INTENSITY AND FREQUENCY OF THE ADVERSE EVENTS ACCORDING TO CTCAE V. 4.03.; Longitudinal extended RASmut ctDNA levels in plasma by ddPCR (end point related to translational objectives 1 and 2). ; Plasma ctDNA landscapes by NGS Candiolo Panel at panitumumab baseline and progression (end point related to translational objectives 3 and 4).
    SOPRAVVIVENZA LIBERA DA PROGRESSIONE (PFS); SOPRAVVIVENZA GLOBALE (OS); INTENSITA' E FREQUENZA DEGLI EVENTI AVVERSI BASATA SU CTCAE V 4.03; Livelli longitudinali di cloni RAS extended mutati in plasma misurati in ddPCR (end point realtivo a obiettivi traslazionali 1 e 2).; Profili molecolari del ctDNA attraverso l’analisi NGS di uno specifico pannello di geni al baseline e alla progressione della terapia con panitumumab (end point relativo a obiettivi traslazionali 3 e 4).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q8 WEEKS (+/- 3 DAYS); THROUGHOUT THE STUDY; THROUGHOUT THE STUDY.; Q2 weeks; At baseline and at disease progression.
    OGNI 8 SETTIMANE (+/- 3 GIORNI); PER TUTTA LA DURATA DELLO STUDIO; PER TUTTA LA DURATA DELLO STUDIO.; Ogni 2 settimane.; Al baseline e a progressione di malattia.
    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 Yes
    E.6.13.1Other scope of the trial description
    TUMOR MOLECULAR ANALYSIS RELATED TO RESPONSE AND RESISTANCE TO PANITUMUMAB.
    ANALISI MOLECOLARE DEL TUMORE IN RELAZIONE ALLA RISPOSTA E ALLA RESISTENZA AL PANITUMUMAB.
    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 No
    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 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 concerned8
    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: 22
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 31
    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)
    AS PER CLINICAL PRACTICE
    SECONDO PRATICA CLINICA
    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 Decision2017-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 15:33:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA