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    Summary
    EudraCT Number:2017-001587-38
    Sponsor's Protocol Code Number:FFCD1605
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-09-08
    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 number2017-001587-38
    A.3Full title of the trial
    A phase II study evaluating FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation
    Etude de phase II évaluant le FOLFOX + PANITUMUMAB selon une stratégie de "stop and go" avec boucle de ré-introduction après progression sous fluoropyrimidine en traitement d'entretien, en 1ère ligne chez des patients atteints d'un adénocarcinome colorectal métastatique sans mutation RAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study assessing antibody adding (panitumumab) to a chemotherapy of reference in metastatic colorectal cancer (FOLFOX), following a strategy with a switch between full treatment and light treatment.
    Etude clinique évaluant l’ajout d’un anticorps (le panitumumab) à une chimiothérapie de référence dans le cancer colorectal métastatique (le FOLFOX), en suivant un schéma alternant un traitement complet avec une phase de traitement allégé.
    A.3.2Name or abbreviated title of the trial where available
    OPTIPRIME
    OPTIPRIME
    A.4.1Sponsor's protocol code numberFFCD1605
    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 supportAMGEN
    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+33380 39 34 83
    B.5.5Fax number+33380 38 18 41
    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 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 bolus use (Noncurrent)
    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.3.11 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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 ELOXATINE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS 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.3.11 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 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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 typeAnticorps IgG2 entièrement humain
    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 adenocarcinoma without a RAS mutation
    adénocarcinome colorectal métastatique sans mutation RAS
    E.1.1.1Medical condition in easily understood language
    patient with a metastatic colorectal cancer
    Patient présentant un cancer colorectal métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 the time to failure of the strategy.
    L’objectif principal est d’évaluer le temps jusqu’à échec de la stratégie.
    E.2.2Secondary objectives of the trial
    - Progression-free survival (PFS) 1 (first radiological progression or death)
    - Successive periods of progression-free survival
    - The best tumour response during treatment, the early response rate at 8 weeks and the maximum depth of response, evaluated according to the RECIST V1.1 criteria according to the investigator and centralised imaging review
    - Overall survival
    - Quality of life of patients (EORTC QLQ-C30)
    - Time to final deterioration of the overall health score
    - Safety profile, particularly in regard to skin toxicity events (acneiform rash, xeroderma, paronychia)
    - The predictive value of early evolution (at two weeks) of the circulating tumour DNA level correlated with the RECIST 1.1 response rate and the PFS 1
    - The appearance of resistance mutations and clonal selection through analysis of circulating tumour DNA every two months.
    - La survie sans progression (SSP) 1 (1ère progression radiologique ou décès)
    - Les survies sans progression successives
    - La meilleure réponse tumorale sous traitement, le taux de réponse précoce à 6 semaines et la profondeur de réponse maximale, évalués selon les critères RECIST V1.1 selon l’investigateur et selon la relecture centralisée des imageries
    - La survie globale
    - La qualité de vie des patients (EORTC QLQ-C30)
    - Le temps jusqu’à détérioration définitive du score de santé globale
    - Le profil de sécurité, en particulier concernant les toxicités cutanées (rash acnéiforme, xérose, paronychie)
    - La valeur prédictive de l’évolution précoce (à 2 semaines) du taux d’ADN tumoral circulant avec corrélation avec le taux de réponse RECIST 1.1 et la SSP 1
    - L’apparition de mutations de résistance et de sélection clonale par l’analyse de l’ADN tumoral circulant tous les deux mois.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Circulating tumour DNA study as potential marker of disease (analyses of circulating tumour DNA level and genetic alterations associated to therapy resistance). Genetic alterations associated to therapy resistance would also be studied from tumor samples.
    Etude de l'ADN tumoral circulant comme marqueur pronostique de la maladie (étude du taux d'ADN tumoral circulant et des altérations génétiques en lien avec une résistance au traitement). La recherche de biomarqueurs prédictifs de l’efficacité de la combinaison FOLFOX + panitumumab en 1ère ligne thérapeutique sera également réalisée à partir d'échantillons tumoraux.
    E.3Principal inclusion criteria
    - Histologically proven colorectal adenocarcinoma without RAS mutation
    - Confirmed, non-resectable metastatic disease (Stage IV)
    - No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
    - At least one measurable metastasis according to the RECIST v1.1 criteria
    - Age ≥ 18 years
    - WHO ≤ 2
    - Neutrophils > 1500 /mm3, platelets> 100 000/mm3, Hb > 9 g/dL
    - Creatinine clearance > 50 mL/min according to the MDRD formula
    - Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases
    - PT > 60%, albumin ≥ 25g/L
    - Estimated life expectancy ≥ 3 months
    - Patient affiliated to a social security scheme
    - Patient informed and informed consent form signed
    - Adénocarcinome colorectal histologiquement prouvé sans mutation RAS
    - Maladie métastatique confirmée et non résécable (Stade IV)
    - Pas de chimiothérapie antérieure exceptée la chimiothérapie péri-opératoire ou adjuvante arrêtée depuis plus de 12 mois
    - Au moins une lésion mesurable métastatique selon les critères RECIST 1.1
    - Age ≥18 ans
    - OMS ≤ 2
    - PNN > 1500 /mm3, plaquettes > 100 000/mm3, Hb > 9 g/dL
    - Clairance de la créatinine > 50 mL/min selon formule MDRD
    - Bilirubinémie < 25 µmol/L, ASAT, ALAT, PAL < 2.5 x LSN ou < 5 x LSN en cas de métastases hépatiques
    - TP > 60%, albumine ≥ 25g/L
    - Esperance de vie estimée ≥ 3 mois
    - Patient affilié au régime de sécurité social
    - Information du patient et signature du consentement éclairé
    E.4Principal exclusion criteria
    - Presence of uncontrolled symptomatic brain metastases
    - RAS mutation (KRAS or NRAS mutation)
    - Patient taking warfarin. If treated with anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion
    - Known DPD deficiency
    - Peripheral neuropathy > 1 (NCI CTCAE v4.0)
    - Patient with interstitial pneumonitis or pulmonary fibrosis
    - History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
    - Poorly controlled chronic skin disease
    - Any known specific contraindication or allergy to the medicinal products used in the study
    - Patient simultaneously included in another clinical trial involving an investigational drug (example: chemotherapy, targeted therapy, immunotherapy)
    - Arterial hypertension not controlled by medical treatment (Systolic BP ≥ 160 mmHg end/or diastolic BP ≥ 90 mmHg)
    - Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
    - The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack
    - Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
    - History of malignant pathologies during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
    - QT/QTc interval > 450 msec for men and > 470 msec for women
    - K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
    - Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test
    - Persons in custody or under wardship
    - Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons
    - Présence de métastase(s) cérébrale(s) symptomatiques non contrôlées
    - RAS muté (KRAS ou NRAS muté)
    - Patient prenant de la coumadine. En cas de traitement anticoagulant à dose efficace indiqué, un relai par héparine de bas poids moléculaire doit être réalisé avant inclusion
    - Déficit connu en DPD
    - Neuropathie périphérique > 1 (NCI CTCAE v4.0)
    - Patient présentant une pneumopathie interstitielle ou une fibrose pulmonaire
    - Antécédent de diarrhée chronique ou de maladie inflammatoire du côlon ou du rectum, ou d’occlusion ou de sub-occlusion non résolues sous traitement symptomatique
    - Pathologie cutanée chronique mal contrôlée
    - Toute contre-indication spécifique ou allergie connue aux médicaments utilisés dans l’étude
    - Patient inclus simultanément dans un autre essai thérapeutique avec une molécule expérimentale (exemple : chimiothérapie, thérapie ciblée, immunothérapie)
    - Hypertension artérielle non contrôlée par un traitement médical (PAS ≥ 160 mmHg et/ou PAD ≥90 mmHg)
    - Toute affection évolutive non équilibrée au cours des 6 derniers mois : insuffisance hépatique, insuffisance rénale, insuffisance respiratoire
    - Atteintes suivantes au cours des 6 mois précédant l’inclusion : infarctus du myocarde, angine de poitrine sévère/instable, pontage aorto-coronarien, insuffisance cardiaque congestive de classe NYHA II, III ou IV, accident vasculaire cérébral ou accident ischémique transitoire
    - Patient transplanté, séropositif pour VIH, hépatite B ou hépatite C, ou autres syndromes d’immunodéficience
    - Antécédent de pathologies malignes dans les 5 dernières années à l’exception du carcinome basocellulaire de la peau ou du carcinome in situ du col utérin correctement traités
    - Intervalle QT/QTc > 450 msec pour les hommes et > 470 msec pour les femmes
    - K+ < LIN, Mg2+ < LIN, Ca2+ < LIN
    - Absence de contraception efficace chez les patients (homme ou/et femme) en âge de procréer, femme enceinte ou allaitante, femme en âge de procréer n’ayant pas réalisé de test de grossesse
    - Personne privée 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)
    time to failure of the strategy
    temps jusqu’à échec de la stratégie
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after last patient registration
    2 ans après le dernier patient inclus
    E.5.2Secondary end point(s)
    - Progression-free survival (PFS) 1 (first radiological progression or death)
    - Successive periods of progression-free survival
    - The best tumour response during treatment, the early response rate at 8 weeks and the maximum depth of response, evaluated according to the RECIST V1.1 criteria according to the investigator and centralised imaging review
    - Overall survival
    - Quality of life of patients (EORTC QLQ-C30)
    - Time to final deterioration of the overall health score
    - Safety profile, particularly in regard to skin toxicity events (acneiform rash, xeroderma, paronychia)
    - The predictive value of early evolution (at two weeks) of the circulating tumour DNA level correlated with the RECIST 1.1 response rate and the PFS 1
    - The appearance of resistance mutations and clonal selection through analysis of circulating tumour DNA every two months.
    - La survie sans progression (SSP) 1 (1ère progression radiologique ou décès)
    - Les survies sans progression successives
    - La meilleure réponse tumorale sous traitement, le taux de réponse précoce à 6 semaines et la profondeur de réponse maximale, évalués selon les critères RECIST V1.1 selon l’investigateur et selon la relecture centralisée des imageries
    - La survie globale
    - La qualité de vie des patients (EORTC QLQ-C30)
    - Le temps jusqu’à détérioration définitive du score de santé globale
    - Le profil de sécurité, en particulier concernant les toxicités cutanées (rash acnéiforme, xérose, paronychie)
    - La valeur prédictive de l’évolution précoce (à 2 semaines) du taux d’ADN tumoral circulant avec corrélation avec le taux de réponse RECIST 1.1 et la SSP 1
    - L’apparition de mutations de résistance et de sélection clonale par l’analyse de l’ADN tumoral circulant tous les deux mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years after last patient registration
    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 No
    E.8.1.2Open No
    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.8.1.7.1Other trial design description
    Monobras
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    stratégie de traitement classique sous FOLFOX (sans stop and go)
    E.8.2.4Number of treatment arms in the trial1
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    LVLS
    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 years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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: 38
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 80
    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 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 state118
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 118
    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 study treatment will be discontinued in the event of:
    -Disease progression on modified FOLFOX 6 + panitumumab
    -Decision of the investigator
    -Major toxicity requiring discontinuation of the treatment
    -A serious or unexpected event requiring the discontinuation of the study treatment
    -Patient refusal or withdrawal of consent
    In all cases of treatment discontinuation, follow-up of the patient will continue according to recommendations of "Thesaurus National de Cancérologie Digestive"
    Les patients seront suivis et traités dès lors qu'ils rentrent en échec de la stratégie selon les recommandations du Thesaurus 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 Decision2017-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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