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    Summary
    EudraCT Number:2014-000805-11
    Sponsor's Protocol Code Number:C26003
    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:2014-07-14
    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 number2014-000805-11
    A.3Full title of the trial
    Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC)
    Studio di Fase 2 su MLN0264 in pazienti precedentemente trattati affetti da adenocarcinoma del pancreas avanzato o metastatico esprimente l’enzima guanilil ciclasi C (GC-C)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate MLN0264 for the treatment of pancreatic tumors which have a protein called Guanylyl Cyclase C (GCC) present, in patients that have been treated previously and in whom the cancer is advanced or has spread.
    Studio per valutare MLN0264 nel trattamento di tumori del pancreas che presentino la proteina chiamata guanilil ciclasi C (GCC), in pazienti precedentemente trattati e in cui ci sia stata progressione o diffusione del tumore.
    A.4.1Sponsor's protocol code numberC26003
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1155-8964
    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 SponsorMillennium Pharmaceuticals, Inc.
    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 supportMillennium Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne St
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 510740-2412
    B.5.5Fax number+1800881-6092
    B.5.6E-mailmedical@mlnm.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 nameMLN0264
    D.3.4Pharmaceutical form Powder for 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 INNNot applicable at this stage
    D.3.9.1CAS number 1514889-12-3
    D.3.9.2Current sponsor codeMLN0264
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Yes
    D.3.11.13.1Other medicinal product typea novel monclonal antibody drug conjugate (ADC)
    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 or Advanced Adenocarcinoma of the Pancreas Expressing Guanylyl Cyclase C (GCC)
    Adenocarcinoma avanzato o metastatico del pancreas che esprime l’enzima guanilil ciclasi C (GCC)
    E.1.1.1Medical condition in easily understood language
    Previously treated tumors consisting of cells from the gastro-intestinal tract located in the pancreas which is advanced or has spread.
    tumori del pancreas precedentemente trattati
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma 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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10051971
    E.1.2Term Pancreatic adenocarcinoma
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10052747
    E.1.2Term Adenocarcinoma pancreas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall response rate (ORR) of patients with advanced or metastatic GCC-positive adenocarcinoma of the pancreas treated with MLN0264
    Valutare il tasso di risposta complessiva dei pazienti affetti da adenocarcinoma recidivante o metastatico GCC-positivo del pacreas e trattati con MLN0264
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile of MLN0264

    To evaluate PFS

    To evaluate duration of response (DOR)

    To evaluate disease control rate (DCR)

    To evaluate OS

    To examine the pharmacokinetic (PK) profile

    To evaluate tumor size reduction

    To investigate the association between GCC expression level and antitumor effects of MLN0264

    To assess immunogenicity of MLN0264
    - valutare il profilo di sicurezza di MLN0264
    - valutare la sopravvivenza libera da progressione (PFS)
    - valutare la durata della risposta (DOR)
    - valutare il tasso di controllo della malattia (DCR)
    - valutare la sopravvivenza globale (OS)
    - esaminare il profilo farmacocinetico (PK)
    - valutare la riduzione delle dimensioni del tumore
    - studiare l'associazione tra livello di espressione GCC ed effetti antitumorali di MLN264
    - valutare l'immunogenicità di MLN0264
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all the following inclusion criteria to be enrolled in the study:

    1. Male or female patients 18 years of age or older when written informed consent is obtained.

    2. Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the pancreas with IHC evidence of GCC expression indicated by an H-score of 10 or greater.

    3. Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the pancreas.

    4. Measurable disease as defined by RECIST version 1.1 guidelines.

    5. ECOG performance status of 0 or 1 within 14 days before enrollment.

    6. Female patients who:

    - Are postmenopausal for at least 1 year before the screening visit, OR
    - Are surgically sterile, OR

    - If they are of childbearing potential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)

    Male patients, even if surgically sterilized (ie, status postvasectomy), who:
    - Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

    7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

    8. Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
    - Absolute neutrophil count (ANC) ≥ 1.5 x109/L
    - Platelet count ≥ 100 x 109/L
    - Hemoglobin ≥ 9 g/dL
    - Activated partial thromboplastin time (aPTT) ≤ 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal range
    - International normalized ratio (INR) ≤ 1.5 x ULN
    - Serum creatinine ≤ 1.5 x ULN
    - Total bilirubin ≤ 1.5 x ULN
    - Albumin ≥ 3g/dL
    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    - Serum lipase ≥ 3 x ULN and serum amylase within the normal range

    9. Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by NCI CTCAE version 4.03.

    10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    Ogni paziente deve soddisfare tutti i seguenti criteri di inclusione per essere arruolati
    nello studio:
    1. pazienti di sesso maschile o femminile di età superiore ai 18 anni al momento della firma del consenso informato.
    2. adenocarcinoma del pancreas metastatico o avanzato inoperabile con espressione di GCC confermata istologicamente con IHC e con H-score di 10 o superiore.
    3. Precedente trattamento con uno o più chemioterapici per adenocarcinoma metastatico o avanzato del pancreas.
    4. Malattia misurabile come definito dalla linee guida RECIST versione 1.1.
    5. ECOG performance status di 0 o 1 entro 14 giorni prima dell’arruolamento.
    6. Pazienti di sesso femminile che:
    - Sono in menopausa da almeno 1 anno prima della visita di screening, oppure
    - Sono chirurgicamente sterili, oppure
    - Se sono in età fertile, acconsentono ad utilizzare2 metodi efficaci di contraccezione dal momento della firma del consenso informato e fino a 30 giorni dopo l'ultima dose del farmaco in studio, oppure
    - concordano a praticare vera astinenza, quando questo è in linea con lo stile di vita preferito e abituale del soggetto. (Astinenza periodica e coito interrotto non sono metodi accettabili di contraccezione).
    Pazienti di sesso maschile, anche se sterilizzati chirurgicamente (cioè, in stato postvasectomia), che:
    - concordano ad utilizzare un metodo contraccettivo barriera efficace durante l'intero periodo di trattamento dello studio e per 4 mesi dopo l'ultima dose del farmaco in studio, oppure
    - concordano a praticare vera astinenza, quando questo è in linea con lo stile di vita preferito e abituale del soggetto. (Astinenza periodica e coito interrotto non sono metodi accettabili di contraccezione).
    7. consenso scritto volontario fornito prima di qualsiasi procedura correlata allo studio e che non sia parte della pratica medica standard, con possibilità di ritiro da parte del paziente in qualsiasi momento
    8. adeguata funzionalità d’organo ed ematologica, come evidenziato dai seguenti valori di laboratorio entro 14 giorni prima dell’arruolamento:
    - conta assoluta dei neutrofili (ANC) ≥ 1,5 x109 / L
    - Conta piastrinica ≥ 100 x 109 / L
    - Emoglobina ≥ 9 g / dl
    - Tempo di tromboplastina parziale attivata (aPTT) ≤ 1,5 volte il limite superiore del range di normalità (ULN) del laboratorio
    - Rapporto internazionale normalizzato (INR) ≤ 1,5 x ULN
    - Creatinina sierica ≤ 1,5 x ULN
    - Bilirubina totale ≤ 1,5 x ULN
    - Albumina ≥ 3g/dL
    - Aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) ≤ 2,5 x ULN
    - Lipasi serica ≥ 3 x ULN e amilasi serica entro il range di normalità
    9. Risoluzione degli effetti tossici di precedenti trattamenti eccetto per alopecia di Grado 0 o 1 da NCI CTCAE versione 4.03.
    10. Disposti e capaci di rispettare le visite programmate, il piano di trattamento, gli
    esami di laboratorio, e le altre procedure dello studio.
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

    1. Radiotherapy within 4 weeks before enrollment

    2. Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy

    3. Female patients who are lactating and breastfeeding or have a positive pregnancy test during the Screening period

    4. Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient
    medication

    5. Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug

    6. Patients with ECG abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc)

    7. Ongoing or clinically significant active infection as judged by the investigator

    8. Signs of PN ≥ NCI CTCAE Grade 2

    9. Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment

    10. Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug

    11. Any preexisting medical condition of sufficient severity to prevent full compliance with the study

    12. History of or current neoplasm other than pancreatic adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri

    13. Known diagnosis of human immunodeficiency virus (HIV) infection

    14. Symptomatic brain metastases

    15. Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin)
    I pazienti che soddisfano uno dei seguenti criteri di esclusione non devono essere
    arruolati nello studio:
    1. Radioterapia nelle 4 settimane precedenti l'arruolamento
    2. Trattamento concomitante o trattamento entro 4 settimane dall’ ingresso nello studio con qualsiasi altro agente sperimentale o chemioterapia
    3. Pazienti di sesso femminile che stanno allattando o hanno un test di gravidanza positivo durante il periodo di screening
    4. malattia cardiovascolare sintomatica non controllata, clinicamente significativa,
    entro 6 mesi prima dell'arruolamento, inclusi infarto miocardico, angina instabile, malattia vascolare periferica di grado 2 o superiore, evento cerebrovascolare, attacco ischemico transitorio, insufficienza cardiaca congestizia, aritmie non controllate tramite medicazione ambulatoriale
    5. Trattamento con qualsiasi farmaco con un potenziale rischio di prolungamento dell'intervallo QT clinicamente rilevante o con rischio di induzione di torsioni di punta che non può essere interrotto o modificato con un farmaco diverso prima di iniziare il trattamento con il farmaco dello studio
    6. Pazienti con anomalie ECG considerate clinicamente significative dallo sperimentatore, o ripetuto prolungamento al basale dell’intervallo QT (QTc)
    7. infezione attiva in corso o clinicamente significativa, su giudizio dello sperimentatore
    8. Segni di PN ≥ NCI CTCAE di Grado 2
    9. Chemioterapia concomitante, terapia ormonale, immunoterapia, o qualsiasi altra forma di trattamento del cancro
    10. Uso di forti inibitori del citocromo P450 (CYP) 3A4 entro 2 settimane dalla prima dose di farmaco in studio
    11. Qualsiasi condizione medica preesistente di severità sufficiente a prevenire piena conformità con lo studio
    12. Storia di neoplasia o neoplasia in corso diversa dall’adenocarcinoma pancreatico, fatta eccezione per il cancro della pelle non melanoma trattati in modo curativo o carcinoma della cervice uterina in situ
    13. Diagnosi nota del virus dell'immunodeficienza umana (HIV)
    14. Metastasi cerebrali sintomatiche
    15. Terapia anticoagulante in corso (ad esempio, aspirina, Coumadin, eparina)
    E.5 End points
    E.5.1Primary end point(s)
    ORR (complete response [CR] + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    ORR (risposta completa [CR] + PR) basata sulla valutazione RECIST versione 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 21 of every other cycle starting with Cycle 2 (ie, Cycles 2, 4, 6, etc.), at EOT, and during Progression Free Survival Follow-up (PFSFU).
    Screening, giorno 21 di ogni ciclo alternato a partire dal ciclo 2 (cioè, cicli 2, 4, 6, ecc), alla fine del trattamento, e durante il Follow-up di sopravvivenza libera da progressione (PFSFU).
    E.5.2Secondary end point(s)
    -AEs, serious adverse events (SAEs), clinical laboratory values, and vital sign measurements
    - Efficacy Endpoints: PFS, DOR, DCR, including CR + PR + SD with minimum 12 weeks duration, OS, Tumor size reduction
    - PK parameters
    - - GCC H-score assessed by immunohistochemistry (IHC)
    - Assessment of antitherapeutic antibodies (ATA)

    - Eventi avversi, eventi avversi gravi (SAE), valori clinici di laboratorio e misura dei segni vitali
    - Endpoint di Efficacia: PFS, DOR, DCR, comprese CR + PR + SD con durata minima di 12 settimane, OS, riduzione delle dimensioni del tumore
    - parametri PK
    - GCC H-score valutato mediante immunoistochimica (IHC)
    - Valutazione degli anticorpi antiterapeutici (ATA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    AEs: From the first dose of study drug to 30 days after the last
    dose.

    SAEs: From the signing of the ICF to 30 days after the last dose

    Clinical laboratory values: Day 1, Day 15 Cycle 1&2; Day 1 Cycle 3+; EoT.

    Vital sign measurements: Screening; Day 1 at 5 and 15 minutes after the start of infusion and upon completion of the infusion for all cycles; EoT.

    Efficacy Endpoints: Screening; Day 21 of every other cycle starting with Cycle 2 (ie, Cycles 2, 4, 6, etc.); EOT, and during PFSFU.

    PK parameters: Specified timepoints on Day 1 all cycles; Day 3, Day 4, Day 8 & Day 15 Cycles 1 to 3; Day 4 & Day 8 Cycle 6; EoT.

    GCC H-score assessed by immunohistochemistry (IHC): pre-screening.

    Assessment of antitherapeutic antibodies (ATA): day 1 pre-dose; EoT.
    AE: Da prima dose del farmaco a 30 giorni dopo l'ultima dose.
    SAE: Da firma del ICF a 30 giorni dopo l'ultima dose
    Valori di laboratorio: Giorno 1, Giorno 15 del Ciclo 1 e 2; Giorno 1 del ciclo 3; EoT.
    Misurazioni segni vitali: screening; Giorno 1 a 5 e 15 minuti dopo l’inizio dell’infusione e al termine dell'infusione per tutti i cicli; EoT.
    Endpoint Efficacia: screening; Giorno 21 di ogni ciclo alternato a partire dal Ciclo 2 (cioè, cicli 2, 4, 6, ecc); EOT, e durante PFSFU.
    Parametri farmacocinetici: intervalli di tempo specificati al giorno 1 tutti i cicli; Giorno 3, Giorno 4, Giorni 8 e 15 dei Cicli 1 e 3; Giorni 4 e 8 del Ciclo 6; EoT.
    GCC H-score valutato con immunoistochimica (IHC): pre-screening.
    Valutazione anticorpi (ATA): giorno 1 pre-dose; EoT.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarkers and immunogenicity
    biomarcatori e immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Italy
    Peru
    Spain
    United Kingdom
    United States
    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
    Last Patient Last Visit
    ultima visita dell'ultimo paziente - 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 months9
    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 months9
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 81
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of Care
    terapia standard
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation TrialNetworks
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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