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    Summary
    EudraCT Number:2011-002564-24
    Sponsor's Protocol Code Number:B490
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 number2011-002564-24
    A.3Full title of the trial
    Cetuximab and Cisplatin with or without Paclitaxel in recurrent/metastatic head and neck cancer
    Cetuximab e Cisplatino con o senza Paclitaxel nel tumore testa-collo ricorrente o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cetuximab and Cisplatin with or without Paclitaxel in recurrent/metastatic head and neck cancer
    Cetuximab e Cisplatino con o senza Paclitaxel nel tumore testa-collo ricorrente o metastatico
    A.4.1Sponsor's protocol code numberB490
    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 SponsorISTITUTO NAZIONALE PER LA CURA TUMORI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Serono S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale Tumori
    B.5.2Functional name of contact pointS.S. Tratt. Med. Tumori Testa-Collo
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223903287
    B.5.5Fax number0223903353
    B.5.6E-mailcinzia.molendini@istitutotumori.mi.it
    D. IMP Identification
    D.IMP: 1
    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 ERBITUX*INFUS 1FL 50ML 2MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNCETUXIMAB
    D.3.9.1CAS number 205923564
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeEU/1/04/281/003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 CISPLATINO SANDOZ*EV 50MG 100M
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNCISPLATIN
    D.3.9.1CAS number 15663271
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 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 typesintesi chimica
    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 Yes
    D.2.1.1.1Trade name PACLITAXEL TEVA*EV 50ML 6MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 typesintesi chimica
    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
    Recurrent/metastatic head and neck squamous cell carcinoma
    Carcinoma spinocellulare testa-collo ricorrente/metastatico
    E.1.1.1Medical condition in easily understood language
    Recurrent/metastatic head and neck squamous cell carcinoma
    Carcinoma spinocellulare testa-collo ricorrente/metastatico
    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 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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
    progression-free survival
    sopravvivenza libera da malattia (PFS)
    E.2.2Secondary objectives of the trial
    Overall Survival
    Response Rate
    Toxicity profile
    Pharmacogenomic study of predictive and prognostic markers in tumor tissue
    Pharmacodynamic study of predictive and prognostic serum markers
    Sopravvivenza globale
    Tasso di risposta
    Profilo di tossicità
    Studio di farmacogenomica su marcatori predittivi e prognostici su campioni di tessuto tumorale
    Studio di farmacodinamica su marcatori sierici predittivi e prognostici
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:1.3.5
    Date:2011/05/23
    Title:Pharmacodinamics
    Objectives:On blood/serum samples:
    - Analysis of circulating miRNAs
    - Analysis of circulating ligands of EGFR (TGFalfa, amphiregulin, epiregulin, HB-EGF)
    - Analysis of Hepatocyte-Growth Factor receptor
    - Validation of algorithm based on MALDI MS analysis of pretreatment serum sample, for tumor Epidermal Growth Factor Receptor Pathway Dependence (according to Taguchi (9))
    - Validation of analysis of cytokine and angiogenic factors (according to serum signature of hypoxia-regulated factors (10))
    - Circulating iNKT cells
    FARMACOCINETICA/FARMACODINAMICA:
    Vers:1.3.5
    Data:2011/05/23
    Titolo:Farmacodinamica
    Obiettivi:Su campioni di sangue/siero:
    - Analisi di miRNAs circolanti
    - Analisi di ligandi circolanti di EGFR (TGFalfa, amphiregulin, epiregulin, HB-EGF)
    - Analisi di Hepatocyte-Growth Factor Receptor
    - Validazione di algoritmi basati su analisi MALDI di spettrometria di massa di campioni sierici raccolti prima del trattamento per la dipendenza dalla via di segnalazione di EGFR (in accordo con Taguchi F, JNCI 2007)
    - Validazione dell’analisi su citochine e fattori angiogenici (in accordo con la “signature” sierica di fattori regolati da ipossia , Byers LA, Mol Cancer Ther 2010)
    - Cellule iNKT circolanti
    E.3Principal inclusion criteria
    Signed written informed consent
    - Male or female > 18 years of age
    - Histologically or cytologically confirmed diagnosis of SCCHN
    - Confirmed RM SCCHN (oral cavity, oropharynx, larynx, hypopharynx, paranasal sinus), not suitable for local therapy
    - At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT) must be present
    - At least 6 months since completion of systemic chemotherapy or biologic therapy
    - ECOG Performance Status 0-1
    - Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, haemoglobin > 9 g/dL
    - Adequate liver function: bilirubin < 2 X upper normal limit (except from known medical reason not interfering with liver function, such as Gilbert disease), SGOT, SGPT, AP, GGT < 3 x ULN
    - Adequate renal function: calculated or analysed creatinine clearance > 60 mL/min
    - Tumor tissue of primary or recurrent disease available
    - Blood samples collected before and during the study available
    - If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 2 months post-dosing.
    Firma del consenso informato
    - Soggetto maggiorenne
    - Diagnosi istologica o citologica di carcinoma spinocellulare del testa-collo (SCCHN)
    - Conferma di SCCHN ricorrente/metastatico (cavo orale, orofaringe, laringe, ipofaringe, seni paranasali), non idoneo a terapia locale
    - Almeno una lesione misurabile in accordo con i criteri (&gt; 10 mm con TAC spirale o &gt; 20 mm con TAC convenzionale)
    - Almeno 6 mesi di distanza dall’ultima dose di chemioterapia o terapia biologica
    - ECOG Performance Status 0-1
    - funzione midollare adeguata: neutrofili &gt; 1.5 x 109/L, piastrine &gt; 100 x 109/L, emoglobina &gt; 9 g/dL
    - Funzione epatica adeguata: bilirubina &lt; 2 X ULN (ad eccezione di comorbidità che non interferiscano con la funzione epatica, ad esempio come la malattia di Gilbert), SGOT, SGPT, AP, GGT &lt; 3 x ULN
    - funzione renale adeguata: clearance della creatinina calcolata o analizzata &gt; 60 mL/min
    - Disponibilità di tessuto tumorale primario o ricorrente
    - Disponibilità di prelievo di campioni ematici prima e durante il trattamento
    - In caso di soggetti in età fertile, disponibilità ad usare metodi contraccettivi efficaci per tutta la durata dello studio e fino a 2 mesi dopo l’ultima dose (Pearl Index &lt; 1; ad esempio contraccettivi orali (pillola), spirale ormonale, impianto ormonale, cerotto transdermico, combinazione di due metodi di barriera (preservativo e diaframma), sterilizzazione, astinenza sessuale)
    E.4Principal exclusion criteria
    No previous chemotherapy or biological therapy for recurrent/metastatic disease
    - Nasopharyngeal Tumor
    - Surgery (excluding prior diagnostic biopsy, tracheostomy or gastrostomy), or irradiation within 4 weeks before study entry
    - Other serious illnesses or medical conditions:
    - Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months;
    - Significant neurologic or psychiatric disorders including dementia or seizures;
    - Active uncontrolled infection (requiring IV antibiotics) or known HIV positivity and active tubercolosis;
    - Active disseminated intravascular coagulation;
    - Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
    - Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC V 4.0) grade ≥2 and/or ototoxicity grade ≥2, except if due to trauma or mechanical impairment due to tumor mass;
    - Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease;
    - Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry;
    - Chronic systemic immunosuppressive therapy that can not be interrupted during treatment study;
    - Known allergic/hypersensitivity reaction to any of the components of the treatment;
    - Pregnancy (absence confirmed by serum/urine beta HCG) or breast-feeding;
    - Other active malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
    - Legal incapacity or limited legal capacity;
    - Medical, psychological or socio-geographical condition or situation which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
    - Nessuna precedente chemioterapia o terapia biologica per la malattia ricorrente/metastatica
    - Chirurgia (ad esclusione di biopsie diagnostice, tracheostomia o gastrostomia), o radioterapia nelle 4 settimane precedenti l’arruolamento
    - Altre patologie o condizioni mediche serie
    - Patologie cardiache non controllate da terapie farmacologiche, insufficienza cardiaca di grado 3 o 4 secondo NYHA;
    - Significativi disordini psichiatrici o neurologici, inclusi demenza o convulsioni;
    - Infezioni attive non controllate (che richiedano antibiotici IV) o positività nota all’HIV o alla tubercolosi;
    - Coagulazione disseminata intravascolare attiva;
    - Altre concomitanti condizioni mediche serie che interferiscano con la capacità del paziente di partecipare allo studio;
    - Neuropatie periferiche funzionale secondo di grado 2 e/o ototossicità di grado 2 secondo NCI-CTC, a meno che siano dovute a traume o impedimento meccanico causato dalla massa tumorale;
    - Mestatsi cerebrali e/o del sistema nervosa centrale o malattie leptomeningee documentate o sintomatiche;
    - Precedente partecipazione ad un altro studio clinico o terapia sperimentale nei 30 giorni precedenti l’arruolamento;
    - terapia immunosoppressiva sistemica che non può essere interrotta durante lo studio;
    - Allergie/ipersensibilità note ad uno qualsiasi dei componenti del trattamento;
    - Gravidanza (se confermata con beta-HCG su siero/urine) o allattamento;
    - Altre neoplasie maligne nei 5 anni precedenti, ad eccezione di carcinoma basocellulare della cute o carcinoma pre-invasivo della cervice;
    - Incapacità o capacità limitata legale
    - Condizioni mediche o psicologiche che, su parere dello sperimentatore, non consentirebbero al paziente di completare lo studio o firmare consapevolmente il consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-12 months
    6-12 mesi
    E.5.2Secondary end point(s)
    Overall Survival
    Response Rate
    Toxicity profile
    Pharmacogenomic study of predictive and prognostic markers in tumor tissue
    Pharmacodynamic study of predictive and prognostic serum markers
    Sopravvivenza globale
    Tasso di risposta
    Profilo di tossicità
    Studio di farmacogenomica su marcatori predittivi e prognostici su campioni di tessuto tumorale
    Studio di farmacodinamica su marcatori sierici predittivi e prognostici
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-12 mesi
    6-12 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned25
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state170
    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)
    Follow-up according to istitutional practice and possible second chemotherapy lines
    Follow-up secondo le pratiche del centro ed eventuali trattamenti di seconda linea
    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 Decision2011-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-14
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