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    Summary
    EudraCT Number:2014-004449-28
    Sponsor's Protocol Code Number:PRODIGE37
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-22
    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 number2014-004449-28
    A.3Full title of the trial
    A randomized multicenter phase II trial of a sequential chemotherapy of nab-paclitaxel + gemcitabine followed by FOLFIRI.3 versus nab-paclitaxel + gemcitabine in first line of pancreatic adenocarcinoma
    Essai de phase II randomisé multicentrique évaluant un traitement séquentiel par nab-paclitaxel + gemcitabine et FOLFIRI.3 versus nab-paclitaxel + gemcitabine en 1ière ligne dans les cancers du pancréas métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment by 2 therapeutic strategies (nab-paclitaxel/gemcitabine vs nab-paclitaxel/gemcitabine + folfiri.3) in pancreatic adenocarcinoma
    Traitement par 2 stratégies thérapeutiques (nab-paclitaxel/gemcitabine versus nab-paclitaxel/Gemcitabine + Folfiri.3) dans les cancers pancréatiques métastatiques
    A.3.2Name or abbreviated title of the trial where available
    FIRGEMAX
    FIRGEMAX
    A.4.1Sponsor's protocol code numberPRODIGE37
    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 supportCelgene
    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 pointProject manager
    B.5.3 Address:
    B.5.3.1Street Address7 bd Jeanne d'Arc, BP 87900
    B.5.3.2Town/ cityDIJON cedex 09
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number+33380 39 34 04
    B.5.5Fax number+33380 38 18 41
    B.5.6E-mailmarie.moreau@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 Campto
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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.3.4Pharmaceutical 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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    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: 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 Fluorouracile Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    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.3.4Pharmaceutical 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 INNFLUOROURACIL
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    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 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 Elvorine
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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.3.4Pharmaceutical form Solution for injection
    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 INNAcide folinique
    D.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    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: 4
    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 Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY FRANCE SAS
    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.3.4Pharmaceutical form Powder for 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    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: 5
    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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    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
    pancreas adenocarcinoma metastatic
    Adénocarcinome pancréatique métastatique
    E.1.1.1Medical condition in easily understood language
    advanced pancras cancer
    cancer pancréatique avancé
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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
    Patient rate in live and without radiological and/or clinical progression at 6 months after randomization
    Taux de patients vivants et sans progression radiologique et/ou clinique à 6 mois dans chaque bras.
    E.2.2Secondary objectives of the trial
    Overall survival
    Objective response rate
    Progression free survival
    Time to treatment stop
    Safety (NCI-CTC V4.0)
    Peripheral neuropathy events will be analysez including the use of the Modified Total Neuropathy Score simplified of GCO-Taxane
    Quality of live (QLQ-C30)
    Survie globale
    Taux de réponse objective selon les critères RECIST v1.1
    Survie sans progression
    Temps jusqu'à arrêt du traitement
    Toxicités selon le NCI CTC v4.0
    Toxicités neuropathiques périphériques selon l'échelle mTNS simplifiée
    (Modified Total Neuropathy Score)
    Qualité de vie (questionnaire EORTC QLQ-C30)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of germinal polymorphismes (UGT1A1, ERCC1, MTHFR, DPD, TS,...) as predictive and prospective factors of treatments response
    Research of predictif immunohistochemy biomarkers as response of treatment on tissus samples
    Evaluation des polymorphismes génétiques constitutionnels pouvant influencer l'efficacité et la tolérance des molécules de chimiothérapie
    (UGT1A1, ERCC1, MTHFR, DPD, TS ...).
    Une étude sur coupe de paraffine à la recherche de biomarqueurs immuno-histochimiques prédictifs de réponse aux traitements
    E.3Principal inclusion criteria
    Adénocarcinome of pancreas, histologically or cytologically proved
    Metastatic disease
    The exam of reference prints (CT scan) must be made within 3 weeks before the treatment's initiation
    At least one mesurable lesion according to RECIST V1.1 criteria
    Life expectancy > 3 months
    No prior chemotherapy (expected adjuvant chemotherapy by gemcitabine stopped in 6 months before inclusion)
    No radiotherapy (excepted if there is at least on lestion out of the irradition area)
    18 ans < age > 75 years
    Performance statut (WHO) 0-1
    Polynyclear ≥ 1500/mm3, platelets ≥ 100 000/mm3, hb ≥ 9 g/dL
    ASAT, ALAT < or = 2.5xLNS or < or = 5 x LNS if liver metastasis
    Bilirubine ≤ 1,5 fois la LSN, creatinin < 120μmol / L
    Negative pregnancy test
    Signed informed consent form
    Adénocarcinome du pancréas, histologiquement ou cytologiquement
    prouvé
    Maladie métastatique
    Scanner (ou IRM si scanner contre indiqué) de référence effectué dans les 3 semaines précédant le début du traitement
    Au moins une lésion mesurable selon les critères RECIST v1.1
    Espérance de vie > à 3 mois
    Aucune chimiothérapie antérieure (chimiothérapie adjuvante par gemcitabine est autorisée si administrée plus de 6 mois avant l'inclusion)
    Pas de radiothérapie précédente (sauf si au moins une lésion cible mesurable en dehors de la zone d'irradiation)
    18 ans < âge < 75 ans
    Etat général : OMS < 2
    PNN ≥ 1500/mm3, plaquettes ≥ 100 000/mm3 hémoglobine ≥ 9 g/dL
    ASAT (SGOT), ALAT (SGPT) ≤ 2,5 fois la LSN ou ≤ 5 fois la LSN en cas de métastases hépatiques avérées
    Bilirubine ≤ 1,5 fois la LSN, créatinine < 120μmol/L, ou clairance MDRD de la créatinine > 60 mL/min
    Les femmes en âge de procréer doivent avoir un test de grossesse négatif (β HCG) avant le début du traitement
    Les femmes en âge de procréer ainsi que les hommes (ayant des rapports sexuels avec des femmes en âge de procréer) doivent s'engager à utiliser un moyen de contraception efficace, sans interruption et pendant toute la durée du traitement.
    Patient affilié au régime de sécurité social
    Information du patient et signature du consentement éclairé
    E.4Principal exclusion criteria
    Another type of pancreas tumor, as endocrine tumor ou with acinous cells
    Ampulloma
    Cerebral or meningeal metastasis
    Gilbert disease
    Neuropathie > or = grade 1
    Study treatments contraindication
    Uncontrolled diarrhoea or inflamatory disease of colon or rectum, or
    bowel obstruction or bowel sub-obstruction no resolved with specific treatment
    Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease prevent patient to receive study treatments
    Cancer within the 5 years before inclusion, except for int situ cancer of the neck of the uterus or basal cell skin cancer
    Significant previous cardiac and respiratory disease
    Patient included in an other therapeutic study with experimental treatment
    Breast feeding
    Patient depreved of freedom or under gardianship
    Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    Autres types de tumeurs du pancréas, en particulier tumeur endocrine ou à cellules acineuses
    Ampullome
    Présence de métastases cérébrales ou méningées, présence de
    métastases osseuses
    Maladie de Gilbert
    Présence de neuropathie > ou = grade 1
    Contre-indications spécifiques aux traitements étudiés
    Antécédents de diarrhée chronique ou de maladie inflammatoire du côlon ou du rectum, ou d'occlusion ou de sub-occlusion non résolues sous traitement symptomatique
    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 basocellulaire ou épidermoïde, considérés comme guéri
    Historique significatif de maladie cardiaque ou respiratoire, notamment tout historique de pneumonie interstitielle.
    Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale
    Femme en cours d'allaitement
    Personnes privées de liberté ou sous tutelle
    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)
    Patient rate survival and without progression defined as radiological (RECIST v1.1) and/or clinical according to the investigator during the 6 first months of treatment
    Taux de patients vivants sans progression 6 mois après l'inclusion. La progression est évaluée par l'investigateur cliniquement et/ou radiologiquement selon les critères RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomization of each patient
    6 mois après la randomisation de chaque patient
    E.5.2Secondary end point(s)
    Overall survival = delay between randomization and death (whatever the reason is). Patients alive will be censored at the date of last news.
    Objective reponse rate = complete response rate or partiel response rate on CT scan or MRI (RECIST v1.1 criteria) during all treatment
    The best response treatment = during all treatment
    Progression-free survival will be calculated as the time between randomization date and the date of the first progression (local, metastatic or clinical) or the date of death (whatever the reason)
    Time to treatment stopped = delay between randomization date and date of treatment stopped (whatever the reason)
    Patients alive without any progression will be censored at the date of last news.
    Efficacy during all treatment
    Time to first apparition of the toxicity grade 3 or 4 (NCI-CT v4.0)
    Quality of live
    La survie globale : définie comme l'intervalle de temps entre la date de randomisation et la date de décès (quelle que soit la cause). Les patients
    vivants seront censurés à la date de point ou à la date de dernières nouvelles
    Le taux de réponse objective (RO): défini comme le taux de réponse complète ou partielle en imagerie selon les critères RECIST v1.1 sur l'ensemble du traitement
    La meilleure réponse au traitement sera évaluée à partir des imageries sur l'ensemble du traitement
    La survie sans progression : définie comme l'intervalle de temps entre la date de randomisation et la date de 1ère progression (clinique et/ou radiologique) ou décès (quelle que soit la cause). Les patients vivants sans progression seront censurés à la date de point ou à la date de dernières nouvelles.
    Le temps jusqu'à arrêt du traitement: défini comme l'intervalle de temps entre la date de randomisation et la date d'arrêt du traitement (quelle
    que soit la cause) ou la date de dernières nouvelles pour les patients vivants sans arrêt de traitement.
    Les toxicités évaluées selon le NCI CTC v4.0.
    Les toxicités neuropathiques périphériques évaluées selon l'échelle mTNS simplifié (Modified Total Neuropathy Score of GOG-Taxane scores)
    Le temps jusqu'à première survenue d'une toxicité de grade 3 et 4 : défini comme l'intervalle de temps entre la date de randomisation et la
    première survenue d'un événement de grade 3,4.
    La qualité de vie (évaluée selon le questionnaire EORTC QLQ-C30) : cette échelle à 30 items comporte 15 dimensions permettant de calculer 15
    scores (5 scores d'aptitude fonctionnelle, 8 scores de symptômes, un score global et un score de problèmes financiers). Ces scores seront calculés et décrits à l'inclusion. De manière exploratoire, le temps jusqu'à détérioration du score de santé globale sera calculé : il est défini comme l'intervalle de temps entre la date de randomisation et la date de diminution de plus de 5 points par rapport à l'inclusion (5 points étant considéré comme le inimum pour définir une différence cliniquement significative) ou le décès.
    E.5.2.1Timepoint(s) of evaluation of this end point
    the secondary objectives will be calculated 1 and 2 years after the last patient included
    Les objectifs secondaires seront déterminés 1 an et 2 ans après le dernier patient inclus
    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 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.8.2.4Number 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 concerned60
    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
    The end of the trial is the last visit of the last subject undergoing the trial
    La fin de l'étude correspond à la dernière visite du dernier patient en cours dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state124
    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 progression, patients of the study will be follow up by our investigator accordint to national thesaurus of digestive cancerology (TNCD)
    Après progression de leur maladie sous l'un des traitement de l'étude, les patients seront suivis selon les habitudes du centre et selon les recommandations du thésaurus national de cancérologie
    digestive (TNCD)
    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 Decision2015-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
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