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    Summary
    EudraCT Number:2013-003398-91
    Sponsor's Protocol Code Number:ABI-007-PANC-003
    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:2014-03-10
    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 number2013-003398-91
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Randomized Study of nab-Paclitaxel Plus Gemcitabine versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma
    Studio di fase 3, multicentrico, in aperto, randomizzato con nab®-Paclitaxel somministrato in associazione con Gemcitabina verso Gemcitabina come terapia adiuvante nei soggetti con adenocarcinoma pancreatico asportato chirurgicamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A large clinical study, for patients who have recently undergone surgery to remove some cancerous tissue from the pancreas, to compare post surgery treatment using nab-Paclitaxel and Gemcitibine or Gemcitibine alone.
    Ampio studio clinico per pazienti recentemente sottoposti ad intervento per l’asportazione di tessuto tumorale del pancreas, con l’obiettivo di confrontare il trattamento post-chirurgico mediante impiego di nab-Paclitaxel e Gemcitabina e il trattamento con Gemcitibina in monoterapia
    A.4.1Sponsor's protocol code numberABI-007-PANC-003
    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, Overland Park
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-888-260-1599
    B.5.5Fax number+1 913-266-0394
    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 Yes
    D.2.1.1.1Trade name Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/809 -withdrawn by Sponsor 07Feb2013
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for suspension 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeThe IMP contains an excipient of biological origin, albumin, a non-active stabilising agent. It is derived from human blood subject to approved donor screening and product manufacturing processes.
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabine for Injection 1g
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited, Middlesex (UK)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 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 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
    Subjects With Surgically Resected Pancreatic Adenocarcinoma
    soggetti con adenocarcinoma pancreatico asportato chirurgicamente
    E.1.1.1Medical condition in easily understood language
    Subjects with pancreatic cancer who have recently undergone surgery to remove some of the affected tissue
    Soggetti con carcinoma pancreatico recentemente sottoposti a chirurgia per asportare una parte di tessuto interessato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10033602
    E.1.2Term Pancreatic adenocarcinoma resectable
    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 compare disease-free survival (DFS) between subjects randomized to nabpaclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone
    Confrontare la sopravvivenza libera da malattia (DFS) tra soggetti randomizzati a ricevere nab-paclitaxel in associazione a gemcitabina e soggetti randomizzati a gemcitabina in monoterapia
    E.2.2Secondary objectives of the trial
    -To assess overall survival (OS) between subjects randomized to nab-paclitaxel in combination with gemcitabine and subjects randomized to gemcitabine alone

    - To assess safety and tolerability of the 2 treatment regimens
    • Valutare la sopravvivenza complessiva (OS) tra soggetti randomizzati a ricevere nab-paclitaxel in associazione a gemcitabina e soggetti randomizzati a ricevere gemcitabina da sola
    • Valutare sicurezza e tollerabilità dei 2 regimi di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.

    2. Pancreatic cancer surgical staging: T 1-3, N0-1, M0.

    3. Subject should be able to start treatment no later than 12 weeks postsurgery.

    4. ≥18 years of age at the time of signing the informed consent form (ICF).

    5. ECOG performance status of 0 or 1.

    6. Acceptable hematology parameters:
    - Absolute neutrophil count ≥1500 cell/mm3
    - Platelet count ≥100,000/mm3
    - Hemoglobin (Hgb) ≥9 g/dL

    7. Acceptable blood chemistry levels:
    - AST/ SGOT and ALT/ SGPT ≤2.5 × upper limit of normal range (ULN)
    - Total bilirubin ≤ ULN (subjects with Gilbert’s syndrome can have bilirubin of up to 1.5 x ULN)
    - Alkaline phosphatase ≤ 2.5 x ULN
    - Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead

    8. CA19-9 <100 U/mL assessed within 14 days of randomization

    9. Acceptable coagulation studies as demonstrated by PT and PTT within normal limits
    (±15%)

    10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at
    least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must:
    - Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3 months following the last dose of IP; and
    - Has negative serum pregnancy test (β -hCG) result at screening

    11. Male subjects:
    a. Must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.

    12. Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted.

    13. Be able to adhere to the study visit schedule and other protocol requirements.

    * True abstinence is acceptable 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).
    1. Adenocarcinoma pancreatico duttale resecato confermato istologicamente con resezione completa macroscopica (R0 e R1). Sono esclusi i soggetti con neoplasie neuroendocrine (e di tipo misto).
    2. Stadiazione chirurgica del tumore pancreatico: T 1-3, N0-1, M0.
    3. I soggetti devono essere in grado di iniziare il trattamento entro e non oltre le 12 settimane post-chirurgia.
    4. I soggetti devono avere ≥ 18 anni al momento della sottoscrizione del modulo di consenso informato (ICF).
    5. Performance status secondo ECOG di 0 o 1.
    6. Parametri ematologici accettabili:
    • Conta assoluta dei neutrofili ≥ 1500 cell/mm3
    • Conta piastrinica ≥ 100.000/mm3
    • Emoglobina (Hgb) ≥ 9 g/dL
    7. Livelli accettabili delle analisi chimiche del sangue:
    • AST/ SGOT e ALT/ SGPT ≤ 2,5 × il limite superiore di normalità (ULN)
    • Bilirubina totale ≤ ULN (i soggetti affetti da sindrome di Gilbert possono avere un valore della bilirubina fino a 1,5 x ULN)
    • Fosfatasi alcalina ≤ 2,5 x ULN
    • Creatinina sierica entro i limiti superiori di normalità o clearance calcolata ≥ 50 mL/min/1,73 m2. Se si utilizza la clearance della creatinina, deve essere utilizzato il peso corporeo effettivo per calcolare la clearance della creatinina (ad es. utilizzando la formula di Cockroft-Gault). Per soggetti con un indice della massa corporea (BMI) >30 kg/m2, deve essere utilizzato il peso della massa magra
    8. CA19-9 <100 U/mL valutato entro 14 giorni dalla randomizzazione
    9. Esami della coagulazione accettabili, come dimostrato da PT e PTT entro i limiti della norma (±15%)
    10. Le donne in età fertile (definite come donne sessualmente mature che (1) non abbiano subito interventi di isterectomia [asportazione chirurgica dell'utero] o ooforectomia bilaterale [asportazione chirurgica di entrambe le ovaie] o (2) non siano naturalmente in postmenopausa da almeno 24 mesi consecutivi [ad es. abbiano avuto cicli in qualsiasi momento durante i 24 mesi consecutivi precedenti]) devono:
    • accettare di utilizzare due metodi contraccettivi approvati dal medico (orale, iniettabile, o contraccettivo ormonale impiantabile; legatura delle tube; spirale contraccettiva; contraccettivo di barriera con spermicida; o partner vasectomizzato) durante il trattamento con il farmaco in studio; e per i 3 mesi successivi all’ultima dose di farmaco sperimentale; e
    • risultare negative al test di gravidanza su siero (β -hCG) allo screening
    11. I soggetti di sesso maschile:
    a. Devono praticare astinenza totale o accettare di utilizzare il preservativo durante il rapporto sessuale con una donna in gravidanza o con una donna in età fertile nel corso del periodo di partecipazione allo studio, durante le interruzioni della dose e per 6 mesi dopo l'interruzione dell'IP, anche se sono stati sottoposti a vasectomia riuscita.
    12. Capire e sottoscrivere volontariamente un ICF prima che sia effettuata qualsiasi valutazione o procedura relativa allo studio.
    13. Essere in grado di aderire al programma di visite dello studio e ad altri requisiti del protocollo
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from enrollment:
    1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma

    2. Presence of or history of metastatic pancreatic adenocarcinoma

    3. Any other malignancy within 5 years prior to randomization, with the exception of
    adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer
    (all treatment of which should have been completed 6 months prior to randomization)

    4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy,
    defined as ongoing signs/symptoms related to the infection without improvement despite
    appropriate antibiotics, antiviral therapy, and/or other treatment

    5. Known infection with hepatitis B or C, or history of human immunodeficiency virus
    (HIV) infection, or subject receiving immunosuppressive or myelosuppressive
    medications that would in the opinion of the investigator, increase the risk of serious
    neutropenic complications

    6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their
    excipients

    7. Serious medical risk factors involving any of the major organ systems, or serious
    psychiatric disorders, which could compromise the subject's safety or the study data
    integrity. These include, but are not limited to:
    a. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
    b. History of interstitial lung disease, slowly progressive dyspnea and unproductive
    cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
    hypersensitivity pneumonitis or multiple allergies
    c. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial
    infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
    New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled
    hypertension, clinically significant cardiac dysrhythmia or ECG abnormality,
    cerebrovascular accident, transient ischemic attack, or seizure disorder

    8. Enrollment in any other clinical protocol or investigational study with an interventional
    agent or assessments that may interfere with study procedures

    9. Any significant medical condition, laboratory abnormality, or psychiatric illness that
    would prevent the subject from participating in the study

    10. Any condition including the presence of laboratory abnormalities, which places the
    subject at unacceptable risk if he/she were to participate in the study

    11. Any condition that confounds the ability to interpret data from the study

    12. Unwillingness or inability to comply with study procedures
    1. Pregresso trattamento neoadiuvante o radioterapia per adenocarcinoma pancreatico
    2. Presenza o anamnesi di adenocarcinoma pancreatico metastatico
    3. Qualsiasi altra neoplasia maligna nei 5 cinque anni precedenti la randomizzazione, ad eccezione di carcinoma in situ adeguatamente trattato di cervice, utero o tumore cutaneo non melanomatoso (in relazione alla quale tutto il trattamento deve essere completato entro i 6 mesi precedenti la randomizzazione)
    4. Infezione(i) batterica(che), virale(i), o fungina(e) attiva(e), incontrollata(e) che richieda(no) terapia sistemica, definita(e) come segni/sintomi in corso, relativi ad infezione senza miglioramento nonostante antibiotici appropriati, terapia antivirale, e/o altro trattamento
    5. Infezione nota con epatite B o C, o anamnesi di infezione da virus dell'immunodeficienza umana (HIV), o soggetto ricevente farmaci immunosoppressori o mielosoppressivi che, secondo il parere dello sperimentatore, aumenterebbero il rischio di gravi complicanze neutropeniche
    6. Anamnesi di allergia o ipersensibilità anab-paclitaxel o gemcitabina o a qualsiasi altro eccipiente
    7. Fattori di gravi rischi medici che coinvolgano uno dei principali sistemi di organi, o gravi disturbi psichiatrici, che potrebbero compromettere la sicurezza del soggetto o l'integrità dei dati dello studio. Tali fattori comprendono, a titolo esemplificativo ma non esaustivo, i seguenti:
    a. Anamnesi di disturbi del tessuto connettivo (ad es., lupus, sclerodermia, arterite nodosa)
    b. Anamnesi di disturbi polmonari interstiziali, dispnea lentamente progressiva e tosse non produttiva, sarcoidosi, silicosi, fibrosi polmonare idiopatica, polmonite da ipersensibilità polmonare o allergie multiple
    c. Gli eventi anamnestici sottoelencati entro i 6 mesi precedenti il Giorno 1 del Ciclo 1: infarto miocardico, angina pectoris grave/instabile, innesto per il bypass dell'arteria coronarica/periferica, scompenso cardiaco in III-IV Classe NYHA, ipertensione non controllata, aritmia cardiaca clinicamente significativa o anomalia elettrocardiografica, incidente cerebrovascolare, attacco ischemico transitorio o epilessia
    8. Arruolamento in qualsiasi altro protocollo clinico o studio di ricerca con un agente terapeutico o valutazioni che possano interferire con le procedure dello studio
    9. Qualsiasi condizione medica significativa, anomalia di laboratorio, o malattia psichiatrica tale da impedire al soggetto di partecipare allo studio
    10. Qualsiasi condizione che includa la presenza di anomalie di laboratorio ed esponga il soggetto a rischi inaccettabili qualora dovesse partecipare allo studio
    11. Qualsiasi condizione che disturbi la capacità di interpretare i dati dello studio
    12. Riluttanza o incapacità di rispettare la procedura dello studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be DFS which is defined as the time from the date of randomization to the date of disease recurrence or death, whichever is earlier.
    L'endpoint primario di efficacia è la DFS, definita come il tempo dalla data di randomizzazione alla data di recidiva di malattia o della morte, a seconda di quale di queste circostanze si verifichi per prima
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease recurrence will be determined by the independent radiological review of CT or MRI scans. Subjects who have two or more missing consecutive scheduled tumor assessments prior to disease recurrence will be censored on the previous tumor assessment date. Subjects who do not develop disease recurrence or die will be censored on the date of last tumor assessment.
    The survival distribution of DFS will be estimated using the Kaplan-Meier method
    La recidiva di malattia sarà determinata mediante revisione radiologica indipendente delle TAC o RM. I soggetti ai quali mancano due o più valutazioni del tumore consecutive programmate prima della recidiva di malattia saranno censiti sulla base della precedente data di valutazione del tumore. I soggetti che non sviluppano recidiva della malattia o che muoiono saranno censiti sulla base della data dell’ultima valutazione del tumore disponibile.
    La sopravvivenza libera da malattia sarà valutata con il metodo di Kaplan-Meier
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint will be OS which is defined as the time from the date of randomization to the date of death.
    L'endpoint secondario di efficacia sarà la sopravvivenza complessiva (OS), definita come il tempo dalla data di randomizzazione alla data di morte
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects who are alive will be censored on the last-known-to be- alive date.
    The survival distribution of OS will be estimated using the Kaplan-Meier method
    I soggetti ancora vivi saranno censiti sulla base dell'ultima data alla quale risultano vivi. La distribuzione della sopravvivenza dell'OS sarà stimata utilizzando il metodo di Kaplan-Meier
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Hungary
    Ireland
    Italy
    Korea, Republic of
    New Zealand
    Portugal
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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 the date of receipt of the required data point from all subjects for primary, secondary and/or exploratory analysis, as prespecified in the protocol
    La fine dello studio è definita come la data di ricezione dei dati richiesti da parte di tutti i soggetti per l'analisi primaria, secondaria e/o esplorativa, come prespecificato nel protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 800
    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)
    Post treatment procedures and data collection will follow sponsor procedures for subject safety. Following treatment discontinuation, other treatment options should be discussed with the subject's physician. Patients will be followed for survival. Subjects who discontinue for reasons other than disease progression will continue to undergo CT scans every 8 weeks for the first 24 wks, every 12 wks for the first 3 yrs, every 24 wks thereafter until disease recurrence up to 5 yrs from last treatment
    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 Decision2014-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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