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    Summary
    EudraCT Number:2012-004190-12
    Sponsor's Protocol Code Number:MK8808-003
    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:2013-01-11
    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 number2012-004190-12
    A.3Full title of the trial
    Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of MK-8808 versus MabThera™ in Patients with Advanced CD20-Positive Follicular Lymphoma.
    Studio multicentrico, randomizzato, in doppio cieco per valutare l efficacia e la sicurezza di MK-8808 vs. MabThera in pazienti con linfoma follicolare avanzato CD20-positivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing MK-8808 to MabThera™ in Patients with Advanced Follicular Lymphoma.
    Studio di confronto MK-8808 Vs MabThera in Pazienti con linfoma follicolare avanzato.
    A.3.2Name or abbreviated title of the trial where available
    SAME
    SAME
    A.4.1Sponsor's protocol code numberMK8808-003
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp.,subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 267 305 1419
    B.5.5Fax number001 267 305 1255
    B.5.6E-mailrobin_edwards@merck.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 nameRituximab
    D.3.2Product code MK-8808
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeMK-8808
    D.3.9.3Other descriptive nameMK-8808
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Concentrate for solution for injection/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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Previously untreated patients with CD20-positive follicular lymphoma, Grade 1, 2 or 3a according to the WHO 2008 classification system.
    Pazienti precedentemente non trattati con linfoma follicolare CD-20 positivo di grado 1,2 o 3a secondo la classificazione WHO 2008.
    E.1.1.1Medical condition in easily understood language
    Previously untreated patients with CD20-positive follicular lymphoma, Grade 1, 2 or 3a according to the WHO 2008 classification system
    Pazienti precedentemente non trattati con linfoma follicolare CD-20 positivo di grado 1,2 o 3a secondo la classificazione WHO 2008.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059432
    E.1.2Term Follicular mixed small and large cell lymphoma
    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 the CR+CRu rate of MK-8808 plus CHOP versus MabThera plus CHOP at week 20 (+/- 1 week) after randomization.
    Confrontare il tasso di risposte complete (CR) e risposte complete non confermate (CRu) di MK-8808 più CHOP vs MabThera più CHOP alla settimana 20 ( +/- 1 settimana) dopo la randomizzazione.
    E.2.2Secondary objectives of the trial
    1. To compare MK-8808 plus CHOP versus MabThera plus CHOP with respect to: - Overall Response Rate (CR + CRu + PR at 20 weeks) - Progression Free Survival - Time-to Treatment Failure - Overall Survival 2. To compare MK-8808 plus CHOP versus MabThera plus CHOP with respect to: - Safety - Depletion of CD19-positive B cells - Immunogenicity 3. To evaluate efficacy (CR+CRu rate and secondary endpoints) and safety in patients with the 158V/V, 158V/F and 158F/F germ line genotypes of the FcγRIIIa receptor.
    1) Confrontare MK-8808 più CHOP vs MabThera più CHOP rispettivamente per: Tasso di risposta complessivo (CR + CRu + PR a 20 settimane); sopravvivenza libera da progressione; tempo al fallimento terapeutico; sopravvivenza globale 2) Confrontare MK-8808 più CHOP vs MabThera più CHOP rispettivamente per: sicurezza, deplezione delle cellule B CD19 positive; immunogenicità. 3) Valutare l'efficacioa ( Tasso CR + CRu ed obiettivi secondari) e sicurezza in pazienti con i genotipi del recettore FcγRIIIa 158V / V, 158V / F e 158F / F germinale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient understands the study procedures, alternative treatments available, the risks involved with the study, and agrees to participate by giving informed consent. 2. Patient is male or female, and ≥18 years of age on the day of signing informed consent. 3. Patient has a life expectancy >3 months with no expected need of immediate intervention to treat life threatening complications. 4. Patient has a histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2 or 3a according to the WHO 2008 classification system (see Appendix 6.3), the biopsy must be comprised of <50% diffusearchitectural pattern (i.e., the follicular pattern component must be 50%), and areas of diffuse architecture may not show histological characteristics of diffuse large B-cell lymphoma. A surgical lymph node excision or biopsy is highly preferred as tissue source for pathological diagnosis. A core needle biopsy is acceptable if there are no palpable peripheral lymph nodes available for surgical excision or biopsy. A core needle biopsy requires a minimum needle size of 16 gauge. A bone marrow aspirate or biopsy is not acceptable for the sole diagnosis of FL in this study. 5. Patient has Ann Arbor Stage III or IV (See Appendix 6.4) and, in the opinion of the investigator, patient requires chemo immunotherapy. Common reasons for initiation of chemo-immunotherapy include (but are not exclusive to): - Rapid clinical lymphoma progression - Bulky disease (e.g., nodal or extranodal mass >6 cm in its greatest diameter) - Symptomatic enlargement of spleen or liver Vital organ compression - Ascites or pleural effusion - Cytopenia secondary to lymphoma - B symptoms (e.g. fever >38°C without infection; drenching night sweats; unexplained loss of >10% body weight within the preceding 6 months) 6. Patient has at least one bi-dimensionally measureable lesion and that lesion must not have been previously irradiated. 7. Patient has Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix 6.2). 8. Female patients of childbearing potential (defined as women who have not been surgically sterilized or have not been free from menses for > 2 years) have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
    1.Ottenimento del consenso informato del/la paziente alla partecipazione. 2.Soggetti di entrambi i sessi di età ≥18 anni. 3.Aspettativa di vita &gt;3 mesi senza necessità prevista di un intervento immediato per il trattamento di complicanze che mettono a rischio la vita del/la paziente. 4.Diagnosi istologicamente confermata di linfoma follicolare CD20-positivo di Grado 1, 2 o 3 in base al sistema di classificazione dell’OMS del 2008. 5.Stadio Ann Arbor III o IV e necessità, secondo il giudizio dello sperimentatore, di chemio-immunoterapia. 6.Almeno 1 lesione misurabile bidimensionalmente e non precedentemente irradiata. 7.Indice di performance ECOG (Eastern Cooperative Oncology Group) ≤2. 8.Donne in età fertile risultate negative a un test di gravidanza su urine effettuato nelle 72 ore precedenti la somministrazione della prima dose di farmaco in studio. 9.Le pazienti in età fertile devono essere disposte a utilizzare 2 metodi di contraccezione o essere chirurgicamente sterili oppure devono astenersi dall’attività eterosessuale per l’intera durata dello studio e per 12 mesi dopo l’ultima dose di farmaco in studio. I pazienti devono acconsentire a utilizzare un metodo di contraccezione adeguato a partire dalla Visita 1 fino a 90 giorni dopo l’ultima dose di farmaco in studio. 10.Funzionalità degli organi adeguata per la R-CHOP.
    E.4Principal exclusion criteria
    1. Number of circulating lymphatic cells >10,000/mcL. 2. Presence or history of CNS involvement (either CNS lymphoma or lymphomatous meningitis). 3. Prior systemic therapy for FL, including but not limited to chemotherapy, anti- CD20 compounds, immunotherapy and any other type or class of anti-cancer drugs. 4. Prior therapy with an anthracycline (e.g., doxorubicin, epirubicin, liposomal doxorobucin). 5. Radiotherapy within 2 months prior to Cycle 1 Day 1, except involved field irradiation of up to two lesions that will not be used to evaluate disease progression. 6. Patient has a known hypersensitivity to any of the drugs required in this study or to any of the excipients or to murine proteins. 7. Patient with a history of a prior malignancy, with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; or who has undergone therapy with curative intent with no evidence of disease recurrence for five years. 8. Patient is currently participating or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1. 9. Patient has any medical contra-indication for prednisone as being dosed in the CHOP chemotherapy regimen. 10. Patient is in a severely immunocompromised state. 11. Patient has poorly controlled diabetes mellitus. 12. Patient has Grade ≥2 peripheral neuropathy. 13. Patient has one of the following: a. Is HIV-positive b. Is positive for Hepatitis B surface antigen (HBsAg+) or antibodies to Hepatitis B core antigen (anti-HBcAg+) c. Has antibodies to Hepatitis C virus 14. Patient has an active infection, including but not limited to tuberculosis. 15. Patient has severe cardiovascular disease, cardiac heart failure, unstable cardiovascular conditions including recent myocardial infarction, angina, arrhythmias or uncontrolled hypertension.
    1.Cellule linfatiche circolanti &gt;10.000/mcL. 2.Coinvolgimento corrente o pregresso del SNC (linfoma del SNC o meningite linfomatosa). 3.Precedente terapia sistemica per il LF inclusi, a titolo esemplificativo, chemioterapia, composti anti-CD20, immunoterapia e qualsiasi altro tipo o classe di farmaci anticancro. 4.Precedente terapia con un’antraciclina (p. es. doxorubicina, epirubicina, doxorubicina liposomiale). 5.Radioterapia nei 2 mesi precedenti il Giorno 1 del Ciclo 1, tranne irradiazione dell’area interessata fino a un massimo di 2 lesioni che non saranno utilizzate per la valutazione della progressione della malattia. 6.Precedente neoplasia maligna, fatta eccezione per la neoplasia intraepiteliale cervicale, carcinoma cutaneo basocellulare, o precedente terapia con intento curativo senza evidenze di recidiva da cinque anni. 7.Paziente gravemente immunocompromesso. 8.Paziente con Diabete mellito scarsamente controllato. 9.Neuropatia periferica di Grado ≥2. 10.Positività all’HIV o all’antigene di superficie dell’epatite B (HBsAg+) o presenza di anticorpi contro l’antigene core dell’epatite B (anti-HBcAg+) o di anticorpi anti-virus dell’epatite C. 11.Infezione attiva inclusa, a titolo puramente esemplificativo, la tubercolosi. 12.Malattia cardiovascolare grave, insufficienza cardiaca, disturbi cardiovascolari instabili inclusi recente infarto del miocardio, angina, aritmie o ipertensione non controllata. 13.Procedura di chirurgia maggiore (esclusa la biopsia dei linfonodi) nelle 4 settimane precedenti il Giorno 1 del Ciclo 1.
    E.5 End points
    E.5.1Primary end point(s)
    CR+CRu rate: is defined as the proportion of patients who achieve a complete response or unconfirmed complete response per centrally assessed IWG 1999 criteria [25]. LIST OF SAFETY MEASUREMENTS (Refer to the Study Flow Charts in Section 1.7 of the study protocol for time points and other details regarding these measurements.): - Evaluation of adverse experiences - PE - Vital signs - ECOG Performance Status (see Appendix 6.2) - CBC & Blood Chemistry (see Appendix 6.1) - CD19-positive B-cells - Serum immunoglobulins - ECHO or MUGA
    Tasso CR+CRu: definito come la proporzione di pazienti che raggiunge una risposta completa o una risposta completa non confermata secondo criterio IWG 1999 valutato centralmente. Elenco delle valutazioni di sicurezza: Valutazioni degli eventi avversi; Esame obiettivo, Segni vitali, Indice di performance ECOG; parametri meatochimici; Cellule B CD19 positive, immunoglobulina serica, ECHO o MUGA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed when all patients have either completed the week 20 CT scan assessment, plus or minus 1 week from randomization, or discontinued the study.
    Questo end point sarà valutato quando tutti i pazienti avranno completato la scansione CT alla settimana 20 ( +/- 1 settimana dalla randomizzazione) oppure saranno discontinuati dallo studio.
    E.5.2Secondary end point(s)
    - Overall response rate (Overall RR): is defined as the proportion of patients who achieve a complete response, an unconfirmed complete response, or a partial response (CR+CRu+PR) per centrally assessed IWG 1999 criteria [25]. - Progression Free Survival (PFS): is defined as the time from randomization to documented progressive disease by centrally assessed IWG 1999 criteria [25] or death, whichever occurs first. Please see 3.5.5.1 for the definition of censoring for the endpoint. - Time-to Treatment Failure (TTF): is defined as the time from randomization to discontinuation of treatment for any reason, including disease progression (by centrally assessed IWG 1999 criteria [25], treatment toxicity, and death. - Overall Survival (OS): is defined as the time from randomization to death due to any cause. Patients without documented death at the time of analysis will be censored at the date last known to be alive.
    Tasso di risposta complessiva: definito come come la proporzione di pazienti che raggiunge una risposta completa o una risposta completa non confermata, o una risposta parziale (CR+Cru+PR)secondo criterio IWG 1999 valutato centralmente. Sopravvivenza libera da progressione ( PFS): definita come il tempo trascorso tra la randomizzazione e la progressione documentata della malattia secondo criterio IWG 1999 valutato centralmente o morte , o l'evento che occorre prima. Si prega di fare riferimento alla sezione 3.5.5.1 per la definizione di censura per endpoint. tempo al fallimento terapeutico ( TTF) è definito come il tempo trascorso dalla randomizzazione alla interruzone del trattamento per qualsiasi ragione, compresa la progressione della malattia ( secondo criterio IWG 1999 misurato centralmente), tossicità del trattamento, morte. Sopravvivenza complessiva ( OS): definita come il tempo trascorso dalla randomizzazione alla decesso per qualsiasi causa. I pazienti senza morte documentata al momento dell'analisi saranno censurati alla data ultima in cui era noto essere ancora vivi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be assessed when all patients have either completed the week 20 CT scan assessment, plus or minus 1 week from randomization, or discontinued the study.
    L'end point secondario sarà rilevato quando tutti i pazienti avranno completato la scansione CT alla settimana 20 ( +/- 1 settimana dalla randomizzazione) oppure saranno discontinuati dallo 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Argentina
    Australia
    Belarus
    Brazil
    Canada
    Chile
    China
    Croatia
    Egypt
    Georgia
    India
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Peru
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Ukraine
    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
    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 months85
    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.1.1Number of subjects for this age range: 0
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 520
    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)
    All patients will be followed until 5 years from randomization,or documented disease progression,or death, whichever occurs first. Follow-up will include physical examination with clinical disease assessment every 3 to 6 months or more often if clinically indicated.CT scans during follow-up will be performed approxim. every 12 months, at shorter intervals if so required by standard institutional practice or local guidelines, any time when there is clin.susp. of disease progres
    Tutti i pazienti saranno seguiti sino a 5 anni dalla randomizziazione, o sino alla progressione di malattia documentata o morte o qualsiasi occorra prima. I follow up comprenderanno esame fisico con valutazione clinica della malattia ogni 3 6 mesi o più frequente se clin. indicato.Durante il Follow up le scansioni CT avverrano ogni 12 mesi o ad intervalli più brevi se richiesto dalla pratica istituzionale standard o dalle linee guida locali, e quando cè il sospetto di progressione.
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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