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    Summary
    EudraCT Number:2016-001688-35
    Sponsor's Protocol Code Number:APACHE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View 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 number2016-001688-35
    A.3Full title of the trial
    An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors
    Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, da solo o in combinazione con Tremelimumab, in pazienti con neoplasie germinali avanzate e ricadute alla chemioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors
    Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, da solo o in combinazione con Tremelimumab, in pazienti con neoplasie germinali avanzate e ricadute alla chemioterapia
    A.3.2Name or abbreviated title of the trial where available
    An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, a
    Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Dur
    A.4.1Sponsor's protocol code numberAPACHE
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    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 supportAstra Zeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS _ Istituto Nazionale Tumori
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223903766
    B.5.5Fax number0223903991
    B.5.6E-mailliana.bevilacqua@istitutotumori.mi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMEDI4736
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameDurvalumab
    D.3.9.4EV Substance Code-
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTremelimumab
    D.3.2Product code MEDI1123
    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 INNTremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    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 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 Yes
    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
    Advanced and relapsed germ cell tumors
    Neoplasie germinali in fase metastatica ricadute o in progressione dopo trattamento chemioterapico di seconda o terza linea.
    E.1.1.1Medical condition in easily understood language
    Germ cell Tumor
    Neoplasie germinali in fase metastatica ricadute o in progressione dopo trattamento chemioterapico di seconda o terza linea.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10068971
    E.1.2Term Germ cell cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 activity and efficacy of durvalumab and durvalumab+tremelimumab in a population of extensively pre-treated patients with GCT.
    Valutare l¿attivit¿ di un programma di trattamento di salvataggio che prevede la somministrazione di durvalumab o di durvalumab + tremelimumab fino a progressione di malattia.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of the study drug.
    To evaluate the Quality of Life changes during treatment.
    To evaluate the ability of metabolic imaging (by 18Fluoodeoxyglucose positron emission tomography [18FDG-PET/CT]) to evaluate th activity of the study drug(s).
    Valutare la sicurezza e la tollerabilit¿ del trattamento, la qualit¿ della vita e l'efficacia della PET per valutare l'attivit¿ dei farmaci in studio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 01
    Date: 15/03/2016
    Title: An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors
    Objectives: Integrating immunologic and genomic assessments and identifying the profile of patients who are more likely to attain a durable clinical benefit from the investigated treatments.

    Pharmacogenomics
    Version: 01
    Date: 15/03/2016
    Title: An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors
    Objectives: expression profiling of tumor and/or tumor infiltrating immune cells, identification of immunogenic neo-antigens which potentially could promote anti-tumour T-cell response upon treatment, association of mutational load with objective tumor response.

    Life quality
    Version: 01
    Date: 15/03/2016
    Title: An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors
    Objectives: To evaluate the Quality of Life changes diring treatment.

    Farmacogenetica
    Versione: 01
    Data: 15/03/2016
    Titolo: Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, da solo o in combinazione con Tremelimumab, in pazienti con neoplasie germinali avanzate e ricadute alla chemioterapia
    Obiettivi: Ad integrazione dello studio principale ¿ prevista anche una componente traslazionale relativa a biomarkers circolanti e ad analisi su tessuto. Tra i biomarkers circolanti, intendiamo valutare attraverso test di citofluorimetria una serie di citochine e altri fattori potenzialmente in relazione all¿attivit¿ di durvalumab e/o tremelimumab.
    Sul tessuto, verr¿ valutata in immunoistochimica l¿espressione di PD-L1 al fine di ipotizzare un eventuale arricchimento e prosecuzione dell¿arruolamento su popolazioni di soggetti selezionati, secondo gli assunti descritti nei metodi statistici


    Farmacogenomica
    Versione: 01
    Data: 15/03/2016
    Titolo: Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, da solo o in combinazione con Tremelimumab, in pazienti con neoplasie germinali avanzate e ricadute alla chemioterapia
    Obiettivi: Ricerca del profilo di espressione delle cellule tumorali o dell'infiltrato tumorale ed identificazione degli antigeni immunogenici che potenzialmente potrebbero promuovere la risposta anti tumorale delle cellule T . Valutare l'associazione del carico mutazionale rispetto la risposta tumorale

    Qualita' della vita
    Versione: 01
    Data: 15/03/2016
    Titolo: Studio in aperto, randomizzato, di fase 2 con l¿anticorpo anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, da solo o in combinazione con Tremelimumab, in pazienti con neoplasie germinali avanzate e ricadute alla chemioterapia
    Obiettivi: Valutare la qualit¿ della vita durante il trattamento con questionario ESAS
    E.3Principal inclusion criteria
    1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
    2. Age > 18 years at time of study entry
    3. Male or female gender
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    5. Life expectancy of > 12 weeks
    6. Adequate normal organ and marrow function
    7. Histological or clinical diagnosis of GCT.
    8. Availability of archival tumor samples for local assessment (by immunohistochemistry) of PD-L1 expression.
    9. Either gonadal or extragonadal tumor primary.
    10. Failure of =2 prior chemotherapy regimens for metastatic disease (1-2 cycles PEB or 1 cycle carboplatin AUC7 given in the adjuvant setting for clinical stage I disease will not be counted as prior lines).
    11. Failure of high-dose chemotherapy will be allowed.
    12. Brain metastases: patients who present with brain metastases as the sole site of disease relapse/progression are not allowed to enter the study. Otherwise, patients with metastatic disease including brain metastases will be allowed provided that they have been irradiated, are stable from at least 4 weeks, and a wash-out period from steroids has occurred (28 days).
    13. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: =60 years old and no menses for ¿1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
    14. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    • Età = 18 anni.
    • Sesso maschile o femminile.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
    • Ricaduta/Progressione dopo almeno 2 linee di trattamento chemioterapico cisplatino-contenente. Tale condizione è definita come un incremento o una persistente positività di uno o più marcatori tumorali o da un incremento numerico e/o dimensionale di localizzazioni vitali non teratomatose di malattia.
    • E’ ammesso un precedente trattamento chemioterapico ad alte dosi costituito da un singolo o multipli cicli di chemioterapia seguiti da reinfusione di progenitori emopoietici autologhi.
    • Diagnosi istologica e/o clinica di neoplasia germinale (del testicolo o extragonadica).
    • Adeguata funzionalità midollare e d’organo.
    • Consenso informato scritto
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    3. Participation in another clinical study with an investigational product during the last 3 months
    4. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab
    5. History of another primary malignancy except for:
    • Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low potential risk for recurrence
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    6. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =28 days prior to the first dose of study drug
    7. Mean QT interval corrected for heart rate (QTc) =470 ms
    8. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
    9. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy.
    10. Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
    11. Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
    12. Active or prior documented inflammatory bowel disease
    13. History of primary immunodeficiency
    14. History of allogeneic organ transplant
    15. History of hypersensitivity to durvalumab or any excipient
    16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
    17. Known history of previous clinical diagnosis of tuberculosis and active tuberculosis.
    18. History of leptomeningeal carcinomatosis
    19. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab

    22. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
    23. Subjects with uncontrolled seizures.
    24. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
    25. Known allergy or hypersensitivity to IP or any excipient.
    • Co-morbidità ed assunzione cronica di farmaci che compromettono l’esecuzione in sicurezza del trattamento con immunoterapici.
    • Infezioni gravi in atto (di grado > 2 NCI-CTC versione 4.03).
    • Pazienti con ricaduta tardiva (definita come recidiva di malattia dopo 2 anni dal termine del trattamento chemioterapico) e con malattia radicalmente resecabile. Viceversa, i pazienti con malattia non radicalmente operabile possono essere candidabili allo studio, dopo discussione collegiale.
    • Neoplasie precedenti o concomitanti differenti da quella in trattamento fatta eccezione per il carcinoma basocellulare o per ogni precedente neoplasia diagnosticata e curata almento 5 anni prima dell’ingresso nello studio.
    • Ogni condizione medica, psichiatrica o dipendenza che può compromettere l’osservanza delle indicazioni previste nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Complete response plus partial response with negative marker
    tasso di risposte maggiori ( risposte complete e risposte parziali con marcatore negativizzato)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 months
    a 3 mesi
    E.5.2Secondary end point(s)
    Safety ( based on CTCAE v 4.03 ); PD-L1 expression and response /PFS/OS; PFS; OS; quality of life asessment
    ¿ Incidenza, natura e severit¿ di eventi avversi correlati al trattamento in studio, definiti in base ai Common Terminology Criteria for Adverse Events (CTCAE) v4.03.; Espressione di PD-L1 e risposta/PFS/OS (vedi ricerca traslazionale).; Sopravvivenza libera da malattia; sopravvivenza globale; Valutazione della qualit¿ della vita
    E.5.2.1Timepoint(s) of evaluation of this end point
    42 months; at the end of study; 3 months; at 6 months; at the end of the study
    42 mesi; fine studio; 3 mesi; 6 mesi; a fine studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 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 years0
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    the standard of care in practice at the investigator site
    lo standard terapeutico usato durante la normale 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 Decision2016-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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