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    Summary
    EudraCT Number:2015-003301-42
    Sponsor's Protocol Code Number:EMR100070-008
    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:2021-06-08
    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 number2015-003301-42
    A.3Full title of the trial
    A Phase III open-label, multicenter trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma
    Sperimentazione multicentrica di Fase III, in aperto, di avelumab (MSB0010718C) come trattamento di terza linea dell’adenocarcinoma gastrico o del giunto gastro-esofageo non resecabile, recidivante o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab in Third-Line Gastric Cancer
    Avelumab nel tumore gastrico di terza linea
    A.3.2Name or abbreviated title of the trial where available
    Avelumab in Third-Line Gastric Cancer
    Avelumab nel tumore gastrico di terza linea
    A.4.1Sponsor's protocol code numberEMR100070-008
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    A.5.4Other Identifiers
    Name:JAVELINNumber:Gastric 300
    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 Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number00496151725200
    B.5.5Fax number00496151722000
    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 nameAvelumab
    D.3.2Product code [MSB0010718C]
    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 INNAvelumab
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.4EV Substance CodeSUB176547
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 IRINOTECAN HOSPIRA - 20MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100MG/5ML
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA ITALIA S.R.L.
    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.3.1Product nameIrinotecan
    D.3.2Product code [Irinotecan]
    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 INNIRINOTECAN CLORIDRATO TRIIDRATO
    D.3.9.1CAS number 97682-44-5
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.4EV Substance CodeSUB08295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.2.1.1.1Trade name Paclitaxel Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited - Queensway Royal Leamington Spa, Warwickshire CV31 3RW , 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.3.1Product namePaclitaxel
    D.3.2Product code [Paclitaxel]
    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 codeMSB0010718C
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Unresectable, recurrent, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
    Adenocarcinoma gastrico o della giunzione gastroesofagea non resecabile, recidivante, localmente avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    Tumore gastrico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10017761
    E.1.2Term Gastric cancer recurrent
    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
    The primary objective is to demonstrate superiority with regard to overall survival (OS) of avelumab plus best supportive care (BSC) versus physician’s choice (chosen from a pre-specified list of therapeutic options) plus BSC.
    L’obiettivo principale è dimostrare la superiorità in termini di sopravvivenza complessiva (overal survival, OS) di avelumab associato alla migliore terapia di supporto (BSC) rispetto a una terapia a scelta del medico (selezionata da un elenco predefinito di opzioni terapeutiche) associata a BSC.
    E.2.2Secondary objectives of the trial
    • To compare avelumab plus BSC versus physician’s choice plus BSC in regard to the following:
    a.Progression-free survival based on an Independent Review Committee (IRC) assessment
    b.ORR based on IRC assessment
    c.Subject-reported outcomes/quality of life (QoL) using the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ 5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ STO22.
    • To determine the safety and tolerability of avelumab.
    Confrontare avelumab associato a BSC rispetto a una terapia a scelta del medico associata a BSC in relazione a:
    a. Sopravvivenza libera da progressione (PFS) in base alla valutazione di un Comitato di revisione indipendente (IRC).
    b. Tasso di risposta obiettiva (ORR) in base alla valutazione dell’IRC.
    c. Esiti riferiti dal soggetto/della qualità della vita (QoL) utilizzando il Questionario europeo per misurare la qualità della vita (EuroQOL) a 5 dimensioni e 5 livelli (EQ-5D-5L), nonché il Questionario a 30 domande per misurare la qualità della vita QLQ-C30 e il modulo QLQ-STO22 dell’EORTC [European Organization for Research and Treatment of Cancer (Organizzazione europea per la ricerca e il trattamento del cancro)].
    • Determinare la sicurezza e la tollerabilità di avelumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿Male or female subjects aged = 18 years
    ¿Subjects with histologically confirmed unresectable, recurrent, locally advanced or metastatic adenocarcinoma of the stomach or GEJ
    ¿ECOG PS of 0 to 1 at trial entry
    ¿Estimated life expectancy of more than 12 weeks
    ¿Adequate hematological, hepatic and renal functions defined by the protocol
    ¿Negative blood pregnancy test at Screening for women of childbearing potential.
    ¿Highly effective contraception for both male and female subjects if the risk of conception exists
    ¿Other protocol defined criteria could apply
    • Soggetti di sesso maschile o femminile, di età =18 anni
    • Malattia misurabile secondo i criteri RECIST 1.1
    • Soggetti affetti da adenocarcinoma dello stomaco o del giunto gastro-esofageo non resecabile, recidivante, localmente avanzato o metastatico
    • Stato di validità ECOG pari a 0 o 1 all’ingresso nella sperimentazione
    • Aspettativadi vita stimata superiore alle 12 settimane
    • Funzioni ematologiche, epatiche e renaliadeguate, così come definite nel protocollo
    • Test di gravidanza sul sangue negativo allo screening per le donne in età fertile
    • Contraccezione altamente efficace per i soggetti di sesso sia maschile sia femminile se esiste il rischio di concepimento
    • Potrebbero essere validi altri criteri definiti nel protocollo
    E.4Principal exclusion criteria
    ¿Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
    ¿Concurrent anticancer treatment
    ¿Major surgery
    ¿Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <10 mg prednisone daily).
    ¿All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
    ¿Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
    ¿Prior organ transplantation, including allogeneic stem-cell transplantation
    ¿Significant acute or chronic infections
    ¿Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
    ¿Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
    ¿Persisting toxicity related to prior therapy except alopecia
    ¿Neuropathy Grade > 3.
    ¿Pregnancy or lactation
    ¿Known alcohol or drug abuse
    ¿History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
    ¿Clinically significant (i.e., active) cardiovascular disease
    ¿All other significant diseases might impair the subject’s tolerance of trial treatment
    ¿Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
    ¿Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
    ¿Legal incapacity or limited legal capacity
    ¿Subjects will be excluded from the treatment with irinotecan or paclitaxel monotherapy if administration of their chemotherapy would be inconsistent with the current local labeling (for example, in regard to contraindications, warnings/precautions, or special provisions) for that chemotherapy. Investigators should check updated labeling via relevant websites before randomization.
    ¿Subjects should start treatment administration within 28 days after signing the informed consent form (ICF). Treatment administration will start within 4 days after the randomization call.
    ¿Other protocol defined criteria could apply
    • Precedente terapia con qualsiasi anticorpo o farmaco diretto contro proteine coregolatorie delle cellule
    • Trattamento antitumorale concomitante
    • Intervento chirurgico maggiore
    • I soggetti che, per una qualsiasi ragione, ricevono agenti immunosopressivi (per esempio steroidi) dovranno gradualmente ridurre tali farmaci prima dell’avvio del trattamento sperimentale (ad eccezione dei pazienti con insufficienza surrenalica, i quali potranno continuare la terapia corticosteroidea alla dose di sostituzione fisiologica, equivalente a <10 mg di prednisone al giorno).
    • Tutti i soggetti con metastasi cerebrali, salvo coloro che soddisfano i seguenti criteri: a.Le metastasi cerebrali sono state trattate localmente, b. Attualmente non sono presenti sintomi neurologici correlati alla localizzazione cerebrale della malattia (sono accettabili le sequele che siano una conseguenza del trattamento delle metastasi cerebrali)
    • Precedente neoplasia maligna (diversa da tumore allo stomaco) negli ultimi 5 anni ad eccezione di carcinoma cutaneo squamocellulare o basocellulare o di carcinoma in situ (vescicale, cervicale, colorettale, mammario)
    • Precedente trapianto d’organo, compreso il trapianto allogenico di cellule staminali
    • Infezioni croniche acute o significative
    • Malattia autoimmune attiva che potrebbe peggiorare con la somministrazione di un agente immunostimolante
    • Gravi reazioni note di ipersensibilità ad anticorpi monoclonali, eventuale anamnesi di anafilassi o asma incontrollata (ossia 3° più caratteristiche di asma parzialmente controllata)
    • Tossicità persistente collegata a una precedente terapia, ad eccezione dell’alopecia
    • Neuropatia di Grado >3
    • Gravidanza o allattamento
    • Abuso noto di alcol o droghe
    • Anamnesi di malattia intercorrente incontrollata, tra cui ipertensione, infezione attiva, diabete
    • Malattia cardiovascolare clinicamente significativa (ossia attiva)
    • Tutte le altre malattie significative che potrebbero pregiudicare la tolleranza del soggetto al trattamento sperimentale
    • Qualsiasi condizione psichiatrica che potrebbe impedire la comprensione o la sottoscrizione del consenso informato e che limiterebbe la conformità ai requisiti dello studio
    • E’ proibita la vaccinazione nelle 4 settimane dalla prima dose di avelumab e nel corso della sperimentazione, ad eccezione della somministrazione di vaccini inattivi
    • Incapacità legale assoluta o relativa
    • I soggetti saranno esclusi dal trattamento con irinotecan o paclitaxel in monoterapia qualora la somministrazione della loro chemioterapia risultasse imcompatibile con l’attuale etichettatura locale (ad es., in relazione a controindicazioni, avvertenze/precauzioni o disposizioni speciali) per quella chemioterapia. Prima della randomizzazione gli sperimentatori devono controllare l’etichettatura aggiornata sui siti Web pertinenti
    • I soggetti devono iniziare la somministrazione del trattamento entro 28 giorni dalla firma del modulo di consenso informato (informed consent form, ICF). La somministrazione del trattamento inizierà entro 4 giorni dalla telefonata di randomizzazione
    • Potrebbero essere validi altri criteri definiti nel protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Sopravvivenza complessiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time (in months) from date of randomization until date of the first documentation of PD or death by any cause (whichever
    occurs first).
    l’analisi primaria avverrà dopo il verificarsi di 256 decessi e un follow-up minimo di 6 mesi dall’ultimo soggetto randomizzato
    E.5.2Secondary end point(s)
    1. Progression Free Survival (PFS)
    2. Best Overall Response (BOR)
    3. Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire
    4. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status
    5. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC STO22) Questionnaire Scores
    1. Sopravvivenza libera da progressione (PFS)
    2.Migliore risposta complessiva (BOR)
    3.Variazione rispetto al basale del Questionario sugli esiti della salute del questionario europeo sulla qualità della vita a 5 dimensioni (EQ-5D-5L)
    4.Variazione rispetto al basale dello stato di salute globale del Questionario dell’Organizzazione europea per la ricerca e cura del cancro (EORTC QLQ-C30)
    5.Variazione rispetto al basale del Questionario sulla qualità della vita dell’Organizzazione europea per la ricerca e cura del cancro (EORTC 5TO22) – Punteggi del questionario specifici per il tumore allo stomaco.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2: Time from date of randomization up to 5 years 3, 4, 5: Baseline up to 3 years
    l’analisi avverrà dopo il verificarsi di 256 decessi e un follow-up minimo di 6 mesi dall’ultimo soggetto randomizzato
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    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
    Chile
    Colombia
    Hong Kong
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    Romania
    Spain
    Czechia
    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 trial is complete after the last subject comes off treatment and completes the safety follow-up. The sponsor may terminate the study at any time once access to study intervention for participants still benefiting is provisioned via a rollover study, expanded access, marketed product or another mechanism of access as appropriate.
    La sperimentazione è completata dopo che l'ultimo soggetto è uscito dal trattamento e ha completato il follow-up di sicurezza. Lo sponsor può terminare lo studio in qualsiasi momento una volta che l'accesso al farmaco dello studio per i partecipanti che ancora hanno beneficio è fornito tramite uno studio di rollover, accesso ampliato, prodotto commercializzato o altro meccanismo di accesso, a seconda dei casi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days3
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 330
    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)
    After a subject has stopped trial treatment, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    Dopo che un soggetto ha smesso il trattamento in studio, sarà somministrato di consueto, se richiesto, in accordo con lo standard of care del centro e generalmente con la pratica clinica accettata, a seconda dei bisogni medici individuali del soggetto.
    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 Decision2017-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-13
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