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    Summary
    EudraCT Number:2017-001683-37
    Sponsor's Protocol Code Number:PRODIGE55
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001683-37
    A.3Full title of the trial
    SecOnd-line Chemotherapy with RAmucirumab +/- pacliTaxel in Elderly advanced gastric or gastroesophageal junction cancer patients
    SecOnde ligne de Chimiothérapie avec RAmucirumab +/- pacliTaxel chez le sujet âgE avec un cancer avancé de l’estomac ou de la jonction oeso-gastrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SecOnd-line Chemotherapy with RAmucirumab +/- pacliTaxel in Elderly advanced gastric or gastroesophageal junction cancer patients
    SecOnde ligne de Chimiothérapie avec RAmucirumab +/- pacliTaxel chez le sujet âgE avec un cancer avancé de l’estomac ou de la jonction oeso-gastrique
    A.3.2Name or abbreviated title of the trial where available
    SOCRATE
    SOCRATE
    A.4.1Sponsor's protocol code numberPRODIGE55
    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 SponsorFédération Francophone de Cancérologie Digestive
    B.1.3.4CountryFrance
    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 supportLilly
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de Cancérologie Digestive
    B.5.2Functional name of contact pointChef de projet
    B.5.3 Address:
    B.5.3.1Street AddressFaculté de Médecine, 7 bd Jeanne d'Arc, BP 87900
    B.5.3.2Town/ cityDIJON cedex
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number+33380393483
    B.5.5Fax number+33380381841
    B.5.6E-mailflore.geillon@u-bourgogne.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cyramza
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRamucirumab
    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 INNRamucirumab
    D.3.9.1CAS number 947687-13-0
    D.3.9.3Other descriptive nameRAMUCIRUMAB
    D.3.9.4EV Substance CodeSUB32795
    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 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 typeHuman monoclonal antibody (IgG1) humain producted from murin cell line (NS0)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Taxol
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTaxol
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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 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
    Elederly patient with advanced gastric or gastroesophageal junction cancer, after first line chemotherapy
    patient âgé présentant un cancer avancé de l'estomac ou de la jonction oesogastrique, après une première ligne de chimiothérapie
    E.1.1.1Medical condition in easily understood language
    Elederly patient with advanced gastric or gastroesophageal junction cancer, after first line chemotherapy
    patient âgé présentant un cancer avancé de l'estomac ou de la jonction oesogastrique, après une première ligne de chimiothérapie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042080
    E.1.2Term Stomach cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042088
    E.1.2Term Stomach cancer stage IV with metastases
    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
    The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinum-containing treatment has failed.
    The co-primary endpoints are the following:
    - Six months survival rate
    - Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
    L’objectif principal est d'évaluer le taux de survie globale à 6 mois et la qualité de vie à 4 mois d’un traitement par ramucirumab seul ou associé à du paclitaxel chez des patients de 70 ans ou plus ayant un adénocarcinome gastrique ou de la jonction oesogastrique en échec thérapeutique après une première ligne de traitement à base de fluoropyrimidine et sel de platine.
    Les critères de jugement seront les suivants (co-critère) :
    - Le taux de survie globale (ie taux de patients vivants) à 6 mois
    - La qualité de vie évaluée à 4 mois sur les 3 dimensions cibles suivantes du questionnaire EORTC QLQ-ELD14: mobilité, fardeau de la maladie et inquiétudes face au futur
    E.2.2Secondary objectives of the trial
    • Other quality-of-life dimensions at 4 months (EORTC QLQ-C30 questionnaire and other dimensions of the QLQ-ELD14 questionnaire)
    • Time to deterioration of health-related quality of life (EORTC QLQ-C30 & ELD14)
    • Time to deterioration in autonomy (IADL)
    • Overall survival
    • Toxicity (NCI CTC 4.0)
    • Dose intensity for each product
    • Time to treatment failure (time between randomization and disease progression, treatment interruption or death)
    • Progression-free survival (clinical and/or radiological) as determined by the investigator and centralized reading
    • Overall Tumor response rate evaluating to RECIST criteria(if disease is measurable) according to the investigator 's opinion and centralized reading
    • Identify prognostic geriatric factors predictive of treatment efficacy and safety
    • Identify prognostic nutritional factors predictive of treatment safety
    Autres dimensions de la qualité de vie à 4 mois (questionnaire EORTC QLQ-C30 et autres dimensions du questionnaire QLQ-ELD14)
    Temps jusqu’à détérioration de la qualité de vie relative à la santé (EORTC QLQC30 et QLQ-ELD14)
    Temps jusqu’à dégradation de l’autonomie (IADL)
    Survie globale
    Toxicité (NCI CTC 4.0)
    Dose intensité pour chaque produit
    Temps jusqu’à échec du traitement (temps entre la randomisation et la progression de la maladie, l'interruption du traitement ou le décès)
    Survie sans progression (clinique et/ou radiologique) selon l'investigateur et selon la relecture centralisée
    Meilleure réponse tumorale (si maladie mesurable) durant le traitement selon l’investigateur et en relecture centralisée
    Identifier des facteurs gériatriques pronostiques et prédictifs de l’efficacité et de la tolérance du traitement
    Identifier des facteurs nutritionnels pronostiques et prédictifs de la tolérance du traitement
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis of constitutional DNA and circulating tumor DNA will be performed before and during treatment to look for factors predictive of response to treatment
    Pharmacokinetic analysis of ramucirumab to predict response and safety with this treatment
    Analyse de l’ADN tumoral circulant avant et pendant le traitement permettant d’identifier des marqueurs prédictifs ou pronostiques de la réponse au traitement
    Analyse de la pharmacocinétique du ramucirumab pour la prédiction de la réponse et de la tolérance de ce traitement
    E.3Principal inclusion criteria
    • Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
    • Aged ≥ 70 years
    • WHO < 2
    • Estimated life expectancy > 3 months
    • Measurable or non-measurable disease according to RECIST 1.1 criteria
    • Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
    • Adequate hepatic, renal and hematologic function:
    o ANC ≥ 1 500 / mm3, platelets ≥ 100 000 / mm3, hemoglobin ≥ 9 g/dL
    o Blood creatinine ≤ 1.5 x ULN and creatinine clearance (MDRD formula) ≥ 40 mL/min
    o Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN if hepatic metastasis)
    o INR ≤ 1.5 or INR ≤ 3 for patients taking AVK and PTT ≤ 5 seconds above the ULN
    o Dipstick proteinuria ≤ 1+ or 24 hour proteinuria < 1 g in total
    • EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
    • IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
    • Signed informed consent 

    • Adénocarcinome gastrique ou de la jonction oeso-gastrique, métastatique ou localement évolué, non résécable, histologiquement prouvé, quel que soit le statut HER2
    • Patient ≥ 70 ans
    • OMS < 2
    • Espérance de vie estimée > 3 mois
    • Maladie mesurable ou non mesurable selon les critères RECIST 1.1
    • Progression documentée lors d’une première ligne de chimiothérapie ou dans les 4 mois après le dernier cycle administré pour la maladie métastatique ou localement évoluée, ayant compris une fluoropyrimidine et un sel de platine ou de l’irinotécan (avec ou sans anthracycline) ou dans les 6 mois suivant la dernière dose de traitement adjuvant comprenant une fluoropyrimidine et un sel de platine (un traitement par immunothérapie est autorisé)
    • Fonctions hématologique, rénale et hépatique adéquates :
    • PNN ≥ 1 500 / mm3, plaquettes ≥ 100 000/mm3, hémoglobine ≥ 9 g/dl
    • créatininémie ≤ 1,5 x LNS et clairance de la créatinine (MDRD) ≥ 40 ml/min
    • Bilirubine totale ≤ 1,5 x LNS, ASAT et ALAT ≤ 3 x LNS (≤ 5 x LNS en présence de métastases hépatiques)
    • INR ≤1,5 ou INR ≤ 3 pour les patients sous AVK et TCA ≤ 5 secondes sous la LNS
    • Protéinurie sur bandelette ≤ 1+ ou protéinurie des 24 heures < 1 g au total
    • EORTC QLQ-C30 + QLQ-ELD-14, complété, faxé au CRGA
    • Questionnaire gériatrique IADL complété, faxé au CRGA
    • Consentement éclairé signé
    E.4Principal exclusion criteria
    • Known cerebral metastasis
    • Prior treatment by taxanes
    • Prior treatment with an antiangiogenic
    • Neuropathy of grade ≥ 2 (NCI-CTCAE 4.0)
    • Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea
    • GI perforation and/or fistulae in the 6 months preceding randomization.
    • GI bleeding within the last 3 months of grade ≥ 3 (NCI-CTCAE 4.0)
    • Chronic use of antiplatelet drugs (including aspirin, but a daily intake of ≤ 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents
    • Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization
    • A life-threatening episode of pulmonary embolism in the 6 months preceding randomization
    • Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant” during the 3 months prior to first dose of protocol therapy
    • Uncompensated congestive heart failure or uncontrolled arrhythmia
    • Uncontrolled hypertension (≥ 160/100 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy
    • Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
    • Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization
    • Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy
    • Known allergy to paclitaxel or ramucirumab
    • Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated
    • Persons deprived of liberty or under supervision
    • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
    • Métastase cérébrale connue
    • Traitement antérieur par taxanes
    • Traitement antérieur par un antiangiogénique
    • Neuropathie de grade ≥ 2 (NCI-CTCAE 4.0)
    • Occlusion ou sub-occlusion intestinale non résolue ou maladie inflammatoire intestinale (Crohn, recto-colite hémorragique,…) ou résection digestive étendue associée à une diarrhée chronique
    • Perforation digestive et/ou fistule dans les 6 mois précédant la randomisation
    • Saignement digestif datant de moins de 3 mois de grade ≥ 3 (NCI-CTCAE 4.0)
    • Prise chronique d’antiplaquettaires (incluant l’aspirine, mais une prise journalière ≤ à 325 mg/jour est acceptée), d’anti inflammatoires non stéroïdiens (ibuprofène, naproxen), de dipyridamole ou clopidogrel ou agents similaires
    • Tout événement thromboembolique artériel (infarctus du myocarde, angor instable, accident vasculaire cérébral, accident ischémique transitoire,…) dans les 6 mois précédant la randomisation
    • Antécédent d’embolie pulmonaire ayant mis en jeu le pronostic vital dans les 6 
mois précédant la randomisation
    • Thrombose veineuse profonde, ou embolie pulmonaire, ou toute autre thrombose significative (thrombose de la veine porte ou thrombose sur cathéter ou thrombose veineuse superficielle ne sont pas considérées comme significatives) dans les 3 mois précédant le début du traitement protocolaire
    • Insuffisance cardiaque congestive non compensée ou arythmie non contrôlée
    • Hypertension artérielle non contrôlée (≥ 160/100 mm Hg > à 4 semaines) en dépit d’un traitement antihypertenseur correctement observé
    • Cirrhose Child-Pugh B ou C, ou cirrhose (quel que soit le stade) avec antécédent d’encéphalopathie hépatique, ou ascite cliniquement significative (qui requière des diurétiques ou des ponctions) résultant d’une cirrhose.
    • Plaie sérieuse ou non cicatrisée ou ulcère peptique ou fracture dans les 28 jours précédant la randomisation
    • Radiothérapie ou chirurgie majeure dans les 28 jours précédant le début du traitement protocolaire, ou chirurgie mineure/pose de chambre implantable dans les 7 jours précédant le début du traitement protocolaire
    • Allergie connue au paclitaxel ou au ramucirumab
    • Autre cancer concomitant ou antécédents de cancer dans les 5 ans, à l'exception d'un carcinome in situ du col de l'utérus ou d’un carcinome cutané basocellulaire ou épidermoïde ou tout autre carcinome in situ, considéré comme guéri
    • Personne sous tutelle, sous curatelle, et sauvegarde de justice ou personne privée de liberté
    • Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques
    E.5 End points
    E.5.1Primary end point(s)
    - Six months survival rate
    - Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
    • Taux de patients vivants à 6 mois
    • Qualité de vie à 4 mois évaluée sur les 3 dimensions cibles suivantes du questionnaire EORTC QLQ-ELD14: mobilité, fardeau de la maladie et inquiétudes face au futur
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year after last patient inclusion
    un an après le dernier patient inclus
    E.5.2Secondary end point(s)
    • Other quality-of-life dimensions at 4 months (EORTC QLQ-C30 questionnaire and other dimensions of the QLQ-ELD14 questionnaire)
    • Time to deterioration of health-related quality of life (EORTC QLQ-C30 & ELD14)
    • Time to deterioration in autonomy (IADL)
    • Overall survival
    • Toxicity (NCI CTC 4.0)
    • Dose intensity for each product
    • Time to treatment failure (time between randomization and disease progression, treatment interruption or death)
    • Progression-free survival (clinical and/or radiological) as determined by the investigator and centralized reading
    • Overall Tumor response rate evaluating to RECIST criteria(if disease is measurable) according to the investigator 's opinion and centralized reading
    • Identify prognostic geriatric factors predictive of treatment efficacy and safety
    • Identify prognostic nutritional factors predictive of treatment safety
    • Autres dimensions de la qualité de vie à 4 mois (questionnaire EORTC QLQ-C30 et autres dimensions du questionnaire QLQ-ELD14)
    • Temps jusqu’à détérioration de la qualité de vie relative à la santé (EORTC QLQC30 et QLQ-ELD14)
    • Temps jusqu’à dégradation de l’autonomie (IADL)
    • Survie globale
    • Toxicité (NCI CTC 4.0)
    • Dose intensité pour chaque produit
    • Temps jusqu’à échec du traitement (temps entre la randomisation et la progression de la maladie, l'interruption du traitement ou le décès)
    • Survie sans progression (clinique et/ou radiologique) selon l'investigateur et selon la relecture centralisée
    • Meilleure réponse tumorale (si maladie mesurable) durant le traitement selon l’investigateur et en relecture centralisée
    • Identifier des facteurs gériatriques pronostiques et prédictifs de l’efficacité et de la tolérance du traitement
    • Identifier des facteurs nutritionnels pronostiques et prédictifs de la tolérance du traitement
    E.5.2.1Timepoint(s) of evaluation of this end point
    one year after last patient inclusion
    1 an après l'inclusion du dernier patient
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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.8.2.3.1Comparator description
    ramucirumab + paclitaxel
    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 concerned70
    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 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
    Last visit last patient
    Dernière visite du dernier patient inclus dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state112
    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)
    The treatment will be administrated until the disease progresses, unacceptable toxicity occurs (grade 4 toxicity or grade 3 toxicity after the dose has been adjusted twice), the patient refuses or the investigator decides to discontinue treatment.
    In all cases of treatment discontinuation, follow-up of the patient will continue according to recommendations of "Thesaurus National de cancérologie Digestive"
    Les cures seront répétées jusqu’à progression, toxicité inacceptable (toxicité de grade 4 ou de toxicité grade 3 après 2 adaptations de dose), refus du patient ou décision de l’investigateur.
    En cas d’arrêt de la chimiothérapie, le traitement ultérieur sera à la discrétion de l’investigateur, selon les recommandations du Thésaurus National de Cancérologie Digestive.
    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 Decision2018-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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