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    Summary
    EudraCT Number:2014-005614-29
    Sponsor's Protocol Code Number:CC-486-NSCL-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 number2014-005614-29
    A.3Full title of the trial
    A Phase 2 multicenter, randomized, placebo controlled, double-blind study
    to assess the safety and efficacy of CC-486 (oral azacitidine) in
    combination with pembrolizumab (MK-3475) versus pembrolizumab plus
    placebo in subjects with previously treated locally advanced or metastatic
    non-small cell lung cancer
    Studio di fase 2, multicentrico, randomizzato, controllato con placebo, in doppio cieco per valutare la sicurezza e l'efficacia di CC-486 (azacitidina orale) somministrato in combinazione con pembrolizumab (MK-3475) verso pembrolizumab pi¿ placebo in soggetti con tumore del polmone non a piccole cellule localmente avanzato o metastatico precedentemente trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate if CC-486 plus pembrolizumab works and is safe
    in patients with advanced or metastatic non-small cell lung cancer who
    have previously received platinum containing treatment.
    Studio clinico per valutare se CC-486 con pembrolizumab ¿ efficace e sicuro in pazienti con con tumore del polmone non a piccole cellule avanzato o metastatico che hanno ricevuto in precedenza trattamento con platino
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberCC-486-NSCL-001
    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.5.4Other Identifiers
    Name:-Number:-
    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 SponsorCELGENE CORPORATION
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018882601599
    B.5.5Fax number0019132660394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZACITIDINA
    D.3.9.1CAS number 320-67-2
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZACITIDINA
    D.3.9.1CAS number 320-67-2
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNPembrolizumab
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
    Trattamento di seconda linea del carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato o metastatico.
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic non-small cell lung cancer (NSCLC) that has previously been treated with platinum containing regimen
    Carcinoma polmonare non a piccole cellule (NSCLC) avanzato o metastatico che non ¿ stato precedentemente trattato con regime contenente platino.
    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 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteria
    Stimare l'efficacia di CC-486 pi¿ pembrolizumab rispetto a pembrolizumab pi¿ placebo in base alla PFS misurata utilizzando le linee guida RECIST 1.1
    E.2.2Secondary objectives of the trial
    ¿To estimate DCR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    ¿To estimate OS of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    ¿To estimate ORR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    ¿To evaluate safety and tolerability of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    ¿To evaluate the impact of pembrolizumab on the pharmacokinetics of CC-486
    ¿Stimare il tasso di controllo della malattia (DCR) di CC-486 pi¿ pembrolizumab rispetto a pembrolizumab pi¿ placebo
    ¿Stimare la sopravvivenza globale (OS) di CC-486 pi¿ pembrolizumab rispetto a pembrolizumab pi¿ placebo
    ¿Stimare il tasso di risposta oggettiva (ORR) di CC-486 pi¿ pembrolizumab rispetto a pembrolizumab pi¿ placebo
    ¿Valutare la sicurezza e la tollerabilit¿ di CC-486 pi¿ pembrolizumab rispetto a pembrolizumab pi¿ placebo
    ¿Valutare l'impatto di pembrolizumab sulla farmacocinetica di CC-486
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subject is = 18 years of age at the time of signing the informed consent form.
    -Subject has histologically or cytologically confirmed squamous or nonsquamous NSCLC.
    -Subject has stage IIIB or IV NSCLC and was pretreated with only 1 prior systemic platinum based chemotherapy.
    -Subject has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously
    irradiated to assess for PD-L1 status.
    -Subject has radiographically-documented measurable disease, as per RECIST 1.1.
    -Subject has an ECOG performance status of 0 to 1.
    -Subject has adequate organ and bone marrow functions
    -I soggetti devono avere = 18 anni al momento della sottoscrizione del modulo di consenso informato.
    -Il soggetto è affetto da NSCLC squamoso o non squamoso confermato istologicamente o citologicamente.
    -Il soggetto è affetto da NSCLC di stadio IIIB o IV ed ha ricevuto solo 1 precedente chemioterapia sistemica a base di platino.
    -Il soggetto ha fornito un campione di tessuto tumorale fissato in formalina proveniente dalla biopsia di una lesione tumorale eseguita contestualmente o successivamente alla diagnosi di malattia metastatica E su una sede non precedentemente sottoposta a radiazioni per valutare lo stato del PD-L1.
    -Soggetto con malattia misurabile documentata radiograficamente, come da RECIST 1.1.
    -Il soggetto presenta uno stato di performance secondo ECOG di 0 a 1.
    -Il soggetto presenta funzioni del midollo osseo e degli organi adeguate
    E.4Principal exclusion criteria
    -Subject with non-squamous histology has known or unknown sensitizing EGFR and/or positive ALK mutation.
    Note: Subjects with squamous histology and unknown EGFR and ALK mutational status are eligible.
    -Subject has received more than one line of therapy for stage IIIB or IV disease
    -Subject has had radiotherapy <= 4 weeks or limited field radiation for palliation <= 2 weeks prior to starting IP, and/or from whom >= 30% of the bone marrow was irradiated.
    -Subject has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
    -Subject has active autoimmune disease that has required systemic treatment within the past 2 years
    -Subject with uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
    Subjects with controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases (must include radiotherapy and/or surgery) >= 28 days (>= 14 days for stereotactic radiosurgery)
    Patients must not be receiving corticosteroids for brain metastases.
    -Il soggetto con istologia non squamosa presenta una mutazione sensibilizzante dell'EGFR nota o non nota e/o una mutazione ALK positiva nota o non nota.
    Nota: I soggetti con istologia squamosa e stato mutazionale di EGFR o ALK non noto sono eleggibili.
    -Il soggetto ha ricevuto più di una linea di terapia per la malattia di stadio IIIB o IV
    -Il soggetto è stato sottoposto a radioterapia <= 4 settimane o a radioterapia palliativa a campo limitato <= 2 settimane prima dell'inizio della terapia con IP e/o dalla quale è stato irradiato >= 30% del midollo osseo.
    -Il soggetto ha ricevuto un vaccino con virus vivo nei 30 giorni precedenti l'inizio del trattamento pianificato. Sono consentiti vaccini antinfluenzali stagionali che non contengono un virus vivo
    -Il soggetto presenta malattia autoimmune attiva che ha richiesto trattamento sistemico nei 2 anni precedenti
    -Il soggetto presenta metastasi del sistema nervoso centrale (SNC) non controllate o sintomatiche e/o meningite carcinomatosa
    I soggetti con metastasi del SNC asintomatiche possono prendere parte a questa sperimentazione.
    Il paziente deve aver concluso qualsiasi precedente trattamento per la cura delle metastasi del SNC (incluse radioterapia e/o intervento chirurgico) >= 28 giorni (>= 14 giorni per la radiochirurgia stereotassica)
    I pazienti non devono ricevere corticosteroidi per il trattamento di metastasi cerebrali.
    E.5 End points
    E.5.1Primary end point(s)
    PFS measured as time from randomization to progression according to
    RECIST 1.1 (based on Investigator assessment)
    PFS misurata dal momento della randomizzazione alla progressione secondo le linee guida RECIST 1.1 (sulla base della valutazione dello Sperimentatore)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dopo l’osservazione di 70 eventi di PFS
    When 70 PFS events occur
    E.5.2Secondary end point(s)
    1.Number (%) of subjects with SD for >= 18 weeks, complete response (CR) or PR (DCR).
    2.Overall survival.
    3.Number (%) of subjects who achieve an objective CR or PR (ORR).
    4.Safety to include the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, Grade 3-4 TEAEs, TEAEs of special interest, and
    laboratory abnormalities and other safety parameters
    5.Plasma PK parameters such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to
    maximum concentration (Tmax), terminal half-life (t1/2), apparent total body clearance (CL/F) and apparent volume of distribution (Vz/F) for
    CC-486.
    1.Numero (%) di soggetti con malattia stabile (SD) per >= 18 settimane, risposta completa (CR) o PR (DCR).
    2.Sopravvivenza Globale.
    3.Numero (%) di soggetti che raggiungono CR o PR (ORR) oggettive.
    4.Sicurezza per includere l'incidenza degli eventi avversi emergenti dal trattamento (TEAE), TEAE seri, TEAE di grado 3-4, TEAE di interesse particolare e anomalie dei valori di laboratorio e altri parametri di sicurezza.
    5.Parametri PK nel plasma come concentrazione massima osservata (Cmax), area sotto la curva concentrazione-tempo (AUC), tempo alla concentrazione massima (Tmax), emivita terminale (t1/2), clearance corporea apparente totale (CL/F) e volume apparente di distribuzione (Vz/F) per CC-486.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Every 6 weeks from randomization for the first 24 weeks then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent
    2.When 70 deaths occur
    3.Every 6 weeks from randomization for the first 24 weeks then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent
    4.Continuous after informed consent signature
    5.Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
    1.Ogni 6 settimane dalla randomizzazione per le prime 24 settimane e successivamente ogni 9 settimane fino a progressione della malattia o inizio di una nuova terapia anticancro o ritiro del consenso
    2.Dopo l'osservazione di 70 decessi
    3.Ogni 6 settimane dalla randomizzazione per le prime 24 settimane e successivamente ogni 9 settimane fino a progressione della malattia o inizio di una nuova terapia anticancro o ritiro del consenso
    4.Continua dopo la firma del consenso informato
    5.Prima della dose, 0,25, 0,5, 1, 1,5, 2, 2,5, 3, 3,5, 4, 6, e 8 ore dopo la dose
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Germany
    Greece
    Italy
    Spain
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt
    of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    La conclusione dello studio clinico ¿ definita come la data dell'ultima visita dell'ultimo soggetto che conclude il follow-up post-trattamento o la data di ricezione dell'ultimo dato dall'ultimo soggetto, dato necessario per un'analisi primaria, secondaria e/o esplorativa, come preliminarmente specificato nel protocollo, a seconda di quale delle due date sia l'ultima.
    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 months0
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-17. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    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)
    Treatment or care after participation in the trial will be at the investigator's discretion.
    Trattamenti o cure dopo la partecipazione alla sperimentazione saranno a discrezione dello Sperimentatore.
    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 Decision2015-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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