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    Summary
    EudraCT Number:2013-003829-29
    Sponsor's Protocol Code Number:EMR200637-002
    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:2014-01-29
    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 number2013-003829-29
    A.3Full title of the trial
    Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses versus Investigator`s Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects with Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies
    Sperimentazione di fase II, in aperto, randomizzata, controllata, multicentrica volta a valutare 2 dosi di Sym004 rispetto alla scelta dello sperimentatore (miglior terapia di supporto, capecitabina, 5-FU) in soggetti affetti da carcinoma colorettale metastatico con resistenza acquisita agli anticorpi monoclonali anti-EGFR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sym004 versus Standard of Care in metastatic colorectal cancer
    Sym004 rispetto a cura standard per cancro colorettale metastatico
    A.4.1Sponsor's protocol code numberEMR200637-002
    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 KGaA
    B.1.3.4CountryGermany
    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 KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.6E-mailservice@merckgroup.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 nameSym004
    D.3.4Pharmaceutical form 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 INNFutuximab
    D.3.9.1CAS number 1310460-85-5
    D.3.9.2Current sponsor code992 DS
    D.3.9.3Other descriptive nameChimeric IgG anti-EGFR mAb (992)
    D.3.9.4EV Substance CodeSUB33210
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNModotuximab
    D.3.9.1CAS number 1310460-86-6
    D.3.9.2Current sponsor code1024 DS
    D.3.9.3Other descriptive nameChimeric IgG anti-EGFR mAb (1024)
    D.3.9.4EV Substance CodeSUB33211
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 3
    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.2.5The 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 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 INNfluorouracil
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Metastatic colorectal cancer with Acquired Resistance to Anti-EGFR Monoclonal Antibodies
    Carcinoma colorettale metastatico con Resistenza Acquisita agli Anticorpi monoclonali anti-EGFR
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Carcinoma colorettale
    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 10052362
    E.1.2Term Metastatic colorectal cancer
    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 assess the efficacy of 2 different weekly dosing regimens (9 mg/kg
    loading dose followed by 6 mg/kg/week dose versus 12 mg/kg/week) of Sym004 compared with investigator`s choice in terms of overall survival time in subjects with metastatic colorectal cancer (mCRC).
    valutare l’efficacia di 2 diversi regimi di somministrazione settimanale di Sym004 (una dose di carico da 9 mg/kg, cui fa seguito una dose da 6 mg/kg/settimana rispetto a una dose da 12 mg/kg/settimana) rispetto alla scelta dello sperimentatore, relativamente al tempo di sopravvivenza complessiva, in soggetti affetti da carcinoma colorettale metastatico (metastatic colorectal cancer, mCRC).
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of the 2 different weekly dosing regimens of Sym004 in subjects with mCRC in terms of best overall response and progression-free survival time and time to treatment failure;
    - To determine the safety profile of the 2 different weekly dosing regimens;
    - To evaluate the dose intensity for the 2 different weekly dosing regimens;
    - To determine the pharmacokinetic (PK) profile;
    - To evaluate the occurrence of antidrug antibody (ADA);
    - To identify potential predictive biomarkers of response to treatment in blood and tumor tissue;
    - To evaluate quality of life
    • valutare l’efficacia di 2 diversi regimi di somministrazione settimanale di Sym004 in soggetti affetti da mCRC, in termini di miglior risposta complessiva e tempo di sopravvivenza senza progressione, nonché di tempo al fallimento del trattamento;
    • determinare il profilo di sicurezza dei 2 diversi regimi di somministrazione settimanale;
    • valutare l’intensità della dose per i 2 diversi regimi di somministrazione settimanale;
    • determinare il profilo farmacocinetico (pharmacokinetic, PK);
    • valutare la presenza di anticorpi antifarmaco (antidrug antibody, ADA);
    • identificare potenziali biomarcatori predittivi della risposta al trattamento nel sangue e nel tessuto tumorale;
    • valutare la qualità della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent obtained before undergoing any study-related activities
    - Male or female, at least 18 years of age
    - Subjects with histologically or cytologically confirmed mCRC, KRAS WT at initial diagnosis
    - Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
    - Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
    - Measurable disease defined as one or more target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST)
    - Life expectancy of at least 3 months
    - ECOG performance status ≤ 1
    - Other predefined inclusion criteria may apply
    • Consenso informato scritto ottenuto prima di intraprendere qualsiasi attività correlata allo studio
    • Soggetto di sesso maschile o femminile, di almeno 18 anni d’età
    • Soggetti con mCRC confermato istologicamente o citologicamente, con KRAS wild-type (WT) alla diagnosi iniziale
    • Fallimento di o intolleranza ai seguenti trattamenti 5-FU, Oxaliplatino, Irinotecan
    • Resistenza acquisita a mAb anti-EGFR commercializzati come definito nel protocollo
    • Malattia misurabile definita come una o più lesioni target secondo i Criteri di valutazione della risposta nei tumori solidi (Response Evaluation Criteria in Solid Tumors, RECIST)
    • Aspettativa di vita di almeno 3 mesi
    • Stato prestazionale ECOG ≤ 1
    • Possono essere applicati altri criteri di inclusione predefiniti (fare riferimento al protocollo)
    E.4Principal exclusion criteria
    - Pretreatment with regorafenib
    - Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
    - Skin rash Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 from previous anti-EGFR
    therapy at time of randomization
    - Magnesium < 0.9mg/dL
    - Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related
    reactions with anti-EGFR mABs
    - Other predefined exclusion criteria may apply
    • Pre-trattamento con regorafenib.
    • Soggetti che a proprio giudizio e a giudizio dello sperimentatore trarrebbero maggiori benefici dal trattamento con regorafenib (ad eccezione dei Paesi nei quali il regorafenib non è rimborsato)
    • Eritema cutaneo di grado>1 secondo i Criteri terminologici comuni per gli eventi avversi (Common Terminology Criteria for Adverse Events, CTCAE) da precedente terapia anti-EGFR al momento della randomizzazione
    • Magnesio <0,9 mg/dl.
    • Nota ipersensibilità ad uno qualsiasi degli ingredienti del trattamento. Reazioni precedenti note di grado 3-4 all’infusione di mAb anti-EGFR.
    • Possono essere applicati altri criteri di esclusione predefiniti (fare riferimento al protocollo)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival (OS)
    L’endpoint primario è la sopravvivenza complessiva (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS will be evaluated when 181 events of randomized patients are reported; expected in 2.5 years
    La sopravvivenza complessiva sarà valutata quando saranno occorsi 181 eventi; previsti in 2,5 anni
    E.5.2Secondary end point(s)
    - Best overall response according to RECIST v1.1
    - Progression-free survival time
    - Time to treatment failure
    - number of subjects with AEs, serious AEs, treatment emergent AEs, AEs leading to death, and AEs with Grade >= 3 NCI-CTCAE (V.4.03)
    - Relative dose intensity
    - Pharmacokinetic profile (area under curve AUC 0-t, half-life, clearance, volume of distribution, C max, C trough, t max)
    - Host immune response, number of subjects with anti-drug antibodies (ADA)
    - Biomarkers: RAS pathway mutations, HER2 and MET status, EGFR and HER3 ligand levels
    - Quality of life by subject reporting questionnaires using EORTC QLQ-C30 (version 3)
    - Quality of life by subject reporting questionnaires using EORTC QLQ-CR29
    - Quality of life by subject reporting questionnaires using FACT-EGFR18
    • Miglior risposta complessiva in base ai RECIST v1.1
    • Tempo della sopravvivenza senza progressione
    • Tempo fino al fallimento del trattamento
    • numero di soggetti con eventi avversi, eventi avversi gravi, trattamento a seguito di eventi avversi, eventi avversi che portano alla morte, ed eventi aversi con grado> = 3 NCI-CTCAE (v.4.03)
    • Intensità relativa del dosaggio
    • Profilo PK (area sotto la curva AUC 0-t, emivita, clearance, volume di distribuzione, C max, C trough, t max)
    • Risposta immunitaria ospite: numero di soggetti con anticorpi contro il farmaco (ADA)
    • Biomarcatori: Mutazioni della via metabolica RAS, stato di HER2 e MET, livelli di EGFR e del ligando per HER3
    • La qualità della vita del soggetto sulla base del questionario di segnalazione EORTC QLQCR30 (version 3)
    • La qualità della vita del soggetto sulla base del questionario di segnalazione EORTC QLQCR29
    • La qualità della vita del soggetto sulla base del questionario di segnalazione FACT-EGFR18
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints:
    - from randomization until first event, where an event can be a progression [radiologically confirmed or clinical progression] or death due to any cause, where death will only be considered as an event if it occurs within 12 weeks after last tumor response assessment without progression
    Biomarkers:
    - as defined in the protocol
    Pharmacokinetics:
    - as defined in the protocol
    Quality of life:
    - every 3/6 weeks during the Treatment Period
    Safety endpoints:
    - until 28 days after the last IMP administration or up to 21 months
    Dalla randomizzazione fino al primo evento, dove un evento può essere una progressione [radiologicamente confermata o progressione clinica] o la morte per qualsiasi causa, dove la morte verrà considerata solo come un evento se avviene entro 12 settimane dopo l'ultima valutazione della risposta del tumore senza progressione.

    Biomarcatori:
    Come definito nel protocollo

    Farmacocinetica:
    Come definito nel protocollo

    La qualità della vita:
    Ogni 3/6 settimane durante il periodo di trattamento

    Endpoint di sicurezza:
    Fino a 28 giorni dopo l'ultima somministrazione di IMP o fino a 21 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualità della vita
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Austria
    Belgium
    Canada
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Spain
    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
    28 days after the last subject received the last dose of trial treatment or 9 months after last subject randomized, whichever occurs later
    28 giorni dopo che l'ultimo soggetto ha ricevuto l'ultima dose di trattamento di studio o nove mesi dopo l'ultimo soggetto randomizzato, a seconda di quale si verifica più tardi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 240
    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)
    Subjects who have Progressive Disease will be followed up for survival and subsequent anti-cancer treatment every 6 weeks.
    I soggetti che hanno una malattia in progressione verranno seguiti per la sopravvivenza e per il successivo trattamento anti-cancro
    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 Decision2014-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-26
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