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    Summary
    EudraCT Number:2013-004081-33
    Sponsor's Protocol Code Number:FFCD1302
    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:2015-06-17
    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 number2013-004081-33
    A.3Full title of the trial
    EFFICACY AND SAFETY of aflibercept ASSOCIATED WITH A FOLFIRI CHEMOTHERAPY IN 1ST LINE TREATMENT OF PATIENTS SUFFERING FROM METASTATIC COLORECTAL CANCER
    Phase II - single arm - multicenter
    EFFICACITE ET TOLERANCE DE L’AFLIBERCEPT ASSOCIE A UNE CHIMIOTHERAPIE PAR FOLFIRI EN 1ERE LIGNE DE TRAITEMENT CHEZ DES PATIENTS ATTEINTS D’UN CANCER COLORECTAL METASTATIQUE
    Phase II monobras - multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY of aflibercept ASSOCIATED WITH A FOLFIRI CHEMOTHERAPY IN 1ST LINE TREATMENT OF PATIENTS SUFFERING FROM METASTATIC COLORECTAL CANCER
    Phase II - single arm - multicenter
    EFFICACITE ET TOLERANCE DE L’AFLIBERCEPT ASSOCIE A UNE CHIMIOTHERAPIE PAR FOLFIRI EN 1ERE LIGNE DE TRAITEMENT CHEZ DES PATIENTS ATTEINTS D’UN CANCER COLORECTAL METASTATIQUE
    Phase II monobras - multicentrique
    A.3.2Name or abbreviated title of the trial where available
    FFCD1302
    FFCD1302
    A.4.1Sponsor's protocol code numberFFCD1302
    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 (FFCD)
    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 supportSanofi-Aventis Group
    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 pointFFCD
    B.5.3 Address:
    B.5.3.1Street AddressFaculté de Médecine, 7, Boulevard Jeanne d’Arc, BP 87900
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    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 Zaltrap
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAflibercept
    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.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic colorectal cancer
    Cancer colorectal métastatique
    E.1.1.1Medical condition in easily understood language
    Metastatic colorectal cancer
    Cancer colorectal métastatique
    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 PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    To evaluate the patients rate without progression or death at 6 months (RECIST version 1.1) according to the investigator
    Evaluer le taux de patients vivants et sans progression à 6 mois (RECIST version 1.1) selon l’investigateur.
    E.2.2Secondary objectives of the trial
    Overall survival
    Survival without progression
    Overall survival and survival without progression at 2, 4, 6 and 12 months
    Patients rate without progression or death at 6 months (RECIST version 1.1) according to central review
    Time to progression
    Objective response rate (CR + PR) (RECIST version 1.1) at 2, 4, 6 and 12 months
    Disease control rate (CR + PR + SD) (RECIST version 1.1) at 2, 4, 6 and 12 months
    Best tumoral response
    Disease control time (CR, PR, SD)
    Objective response time (CR, PR)
    Safety profile using the NCI CTCAE version 4.0 classification
    Cytokines and regulatory immune cell modulation under therapy (ancillary study)
    Survie globale
    Survie sans progression
    Survie globale et survie sans progression à 2, 4, 6 et 12 mois
    Taux de patients vivants et sans progression à 6 mois (RECIST version 1.1) selon la relecture centralisée
    Temps jusqu’à progression
    Taux de réponse objective [complète (RC) et partielle (RP)] selon les critères RECIST version 1.1 à 2, 4, 6 et 12 mois
    Taux de contrôle de la maladie [RC, RP et stabilisation (SD)] selon les critères RECIST version 1.1 à 2, 4, 6 et 12 mois
    Meilleure réponse tumorale
    Durée de contrôle de la maladie (RC, RP, SD)
    Temps jusqu’à réponse objective (RC, RP)
    Toxicité évaluée grâce à l’échelle NCI-CTCAE version 4.0
    Variation des cytokines et des cellules immunorégulatrices durant le traitement (étude ancillaire)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18 years
    WHO ≤ 2
    Histologically or cytologically confirmed mCRC
    Unresectable metastase(s) and/or non-operable patient
    At least one untreated target lesion that could be measured in one dimension, according to the RECIST criteria
    Absence de traitement antérieur de la maladie métastatique. Adjuvant chemotherapy after primary resection is allowed if last cycle was administered at least 6 months ago.
    Adequate organ function: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L,, Haemoglobin ≥ 9 g/dL, Platelets (PTL) ≥ 85 x 109/L, AST/ALT ≤ 5 x ULN, Gamma-GT ≤ 5 x ULN , Bilirubin ≤ 1.5x ULN, Creatinin clearance ≥ 50 mL/min (Cockcroft and Gault formula),
    Proteinuria < 30 mg/dL; in case of proteinuria ≥ 30 mg/dL on the dipstick, 24 hours proteinuria < 1.5g/24 hours
    Patient who signed the informed consent form
    - Age ≥ 18 ans
    - Etat général OMS ≤ 2
    - Adénocarcinome du rectum ou du côlon métastatique prouvé histologiquement ou sur la tumeur primitive ou une métastase
    - Métastase(s) non résécable(s) et/ou patient non opérable
    - Au moins une cible mesurable selon les critères RECIST version 1.1, non préalablement irradiée
    - Absence de traitement antérieur de la maladie métastatique. Une chimiothérapie antérieure en situation adjuvante achevée 6 mois ou plus, avant le diagnostic de métastase est autorisée
    - Bilan biologique adéquat : Hb ≥ 9 g/dl, polynucléaires neutrophiles ≥ 1500 /mm3, plaquettes ≥ 100 000/mm3, bilirubine totale ≤ 1,5 x LSN, clairance de la créatinine > 50 mL/min (formule de Cockroft and Gault), PAL < 5 x LSN, ASAT et ALAT ≤ 5 x LSN, GGT < 5 x LSN,
    - Protéinurie sur bandelette urinaire < 2+. Si ≥ 2+ faire protéinurie des 24 h qui doit être ≤ 1 g
    - Patient ayant signé le consentement éclairé
    E.4Principal exclusion criteria
    - Patients with clinical symptoms (occlusion, hemorrhage)
    - Présence de métastases cérébrales, de compression non contrôlée de la moelle épinière, de méningite carcinomateuse, de signes d’atteinte cérébrale ou leptoméningée
    - Gilbert's syndrome
    - Uncontrolled hypercalcemia
    - Uncontrolled Hypertension (SAP > 150 mmHg and DAP > 100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy
    - Any progressive unbalanced affection over the last 6 months :: liver failure, kidney failure, respiratory failure
    - Patient presenting with cardiac failure, symptomatic Ischemic heart disease or a symptomatic cardiac event (ischemia, failure) of less than 6 months
    - Atteintes suivantes au cours des 3 mois précédant l’inclusion : saignement/hémorragie gastro-intestinal(e) de grade 3 ou 4, ulcère peptique résistant au traitement, œsophagite ou gastrite érosive, maladie infectieuse ou inflammatoire de l’intestin, diverticulite, embolie pulmonaire ou autre événement thromboembolique non contrôlé, fractures osseuses non cicatrisées
    - Patient who have had Major surgery within the 28 days prior to inclusion
    - Syndrome d’immunodéficience acquise connu (maladies liées au SIDA) ou infection à VIH connue nécessitant un traitement antirétroviral
    - Treated by CYP3A4 inductors, unless stopped more than 7 days before inclusion
    - Patient with previous or concurrent cancer that is distinct in primary site or histology from mCRC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
    - Lack of use of acceptable forms of contraception (male and/or female) in patient of child bearing potential, pregnant or child breastfeeding women, patient of child bearing potential who did not undergo pregnancy test
    - Contraindication for the medicinal product used in that study
    - Unability to comply with the study protocol for geography, social ou phsycological reasons
    - Patient treated with new oral anticoagulants (as rivaroxaban XARELTO®, apixaban ELIQUIS®, dabigatran PRADAXA®) unless AVK
    - Patients présentant des symptômes cliniques (occlusion, hémorragie)
    - Présence de métastases cérébrales, de compression non contrôlée de la moelle épinière, de méningite carcinomateuse, de signes d’atteinte cérébrale ou leptoméningée
    - Maladie de Gilbert
    - Hypercalcémie non contrôlée
    - Hypertension non contrôlée (PAS > 150 mmHg et PAD > 100 mmHg) ou antécédent de crise hypertensive ou d’encéphalopathie hypertensive
    - 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 III ou IV, accident vasculaire cérébral ou accident ischémique transitoire
    - Atteintes suivantes au cours des 3 mois précédant l’inclusion : saignement/hémorragie gastro-intestinal(e) de grade 3 ou 4, ulcère peptique résistant au traitement, œsophagite ou gastrite érosive, maladie infectieuse ou inflammatoire de l’intestin, diverticulite, embolie pulmonaire ou autre événement thromboembolique non contrôlé, fractures osseuses non cicatrisées
    - Acte chirurgical important dans les 28 jours précédant le début du traitement
    - Syndrome d’immunodéficience acquise connu (maladies liées au SIDA) ou infection à VIH connue nécessitant un traitement antirétroviral
    - Traitement par les inducteurs du CYP3A4, sauf si arrêt depuis plus de 7 jours
    - Antécédents d’hémopathie maligne ou de cancer (excepté ceux traités depuis plus de 5 ans et considérés comme guéris), les carcinomes in situ du col utérin et les cancers cutanés traités (mélanome exclu)
    - Absence de contraception efficace chez les patients (homme et/ou femme) en âge de procréer, femme enceinte ou allaitante, femme en âge de procréer n’ayant pas réalisé de test de grossesse
    - Toute contre-indication aux médicaments utilisés dans l’étude
    - Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques
    - Patients sous nouveaux anticoagulants oraux (type rivaroxaban XARELTO®, apixaban ELIQUIS®, dabigatran PRADAXA®) sauf si relais par AVK
    E.5 End points
    E.5.1Primary end point(s)
    The main end point is the patients rate without progression or death at 6 months according to the investigator.
    The progression is defined by:
    • progression assessed by TDM (RECIST version 1.1)
    • any cause of death
    Le critère de jugement principal est le taux de patients vivants et sans progression à 6 mois selon l’investigateur.
    La progression est définie par :
    • La progression évaluée par TDM, selon les critères RECIST version 1.1
    • Le décès quel qu’en soit la cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 months after the inclusion
    à 6 mois après l'inclusion
    E.5.2Secondary end point(s)
    The secondary criteria are :
    Overall Survival is defined as the time from the patient's inclusion to the date of death from any cause or last information if the patient is alive.
    Rate of patients alive and without progression at 6 months (RECIST version 1.1) centralized review.
    Survival without progression is defined as the time between the inclusion date and the date of the first documented progression assessed according to the investigator by RECIST criteria version 1.1 or the death from any cause or the date of the last information if the patient is alive.
    Overall survival and survival without progression will be assessed at 2, 4, 6 and 12 months after the inclusion, median will also be assessed.
    Time to progression is defined as the time from the inclusion to the date of documented progression defined according to the investigator by RECIST criteria version 1.1.
    The rate of the objective response is defined as the number of patients having one PR or one CR, response assessed according to the investigator by RECIST criteria version 1.1 at 2, 4, 6 and 12 months.
    Time to the objective response (CR and PR) is defined as the time between the inclusion date and the partial or complete response assessed according to the investigator by RECIST criteria version 1.1
    Disease Control rate (CR + PR + SD) is defined as the number of patients with documented partial response, complete response or stable disease defined assessed according to the investigator by RECIST criteria version 1.1 at 2, 4, 6 and 12 months
    Survival rate without progression at 6 month, progression assessed according to the centralized review
    Best response rate (CR, PR, SD or P), response assessed according to the investigator by RECIST criteria version 1.1
    Toxicities will be described NCI-CTCAE classification version 4.0
    Les critères de jugement secondaires sont :
    La survie globale est définie comme le délai entre la date d’inclusion du patient et le décès du patient ou la date de dernières nouvelles si le patient est vivant.
    Taux de patients vivants et sans progression à 6 mois (RECIST version 1.1) selon la relecture centralisée.
    La survie sans progression est définie comme le délai entre la date d’inclusion et la date de première progression radiologique évaluée selon l’investigateur par les critères RECIST version 1.1 ou le décès (quelle que soit la cause) ou la date de dernières nouvelles si le patient est vivant sans progression.
    La survie globale et la survie sans progression seront estimées à 2, 4, 6 et 12 mois après l’inclusion et les médianes seront également estimées.
    Le temps jusqu’à progression est défini comme le délai entre la date d’inclusion et la date de la progression évaluée selon l’investigateur par les critères RECIST version 1.1.
    Le taux de réponse objective (RC et RP) est défini comme le nombre de patients ayant une RP ou une RC, réponse évaluée selon l’investigateur par les critères RECIST version 1.1 à 2, 4, 6 et 12 mois.
    Le temps jusqu’à réponse objective (RC et RP) est défini comme le délai entre la date d’inclusion et la date de la réponse complète ou partielle, réponse évaluée selon l’investigateur par les critères RECIST version 1.1.
    Le taux de contrôle de la maladie (RC, RP et SD) est défini par le nombre de patients ayant une RC, RP ou une stabilité de la maladie, réponse évaluée selon l’investigateur par les critères RECIST version 1.1 à 2, 4, 6 et 12 mois.
    La durée de contrôle de la maladie est définie comme le délai entre la date d’inclusion et la date de la première progression chez les patients ayant présenté une réponse complète, une réponse partielle ou une stabilité, réponse évaluée selon l’investigateur par les critères RECIST version 1.1.
    Le taux de patients vivants et sans progression à 6 mois, progression évaluée selon la relecture centralisée.
    Le taux de meilleure réponse (RC,RP, SD ou P), réponse évaluée selon l’investigateur par les critères RECIST version 1.1.
    Les toxicités seront décrites selon la classification NCI-CTCAE version 4.0 et selon les grades.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 2, 4, 6 and 12 months after inclusion
    A 2, 4, 6 et 12 mois après l'inclusion
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned15
    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
    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 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state54
    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)
    None
    Non
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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