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    Summary
    EudraCT Number:2013-001275-21
    Sponsor's Protocol Code Number:IriGen
    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:2013-06-03
    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 number2013-001275-21
    A.3Full title of the trial
    Phase II study: individualization of dosage of irinotecan in the FOLFIRI according to the genetic polymorphism of UGT1A1 in the first line treatment of metastatic colorectal cancer
    Etude de phase II : individualisation de la posologie d'irinotécan dans le protocole FOLFIRI selon le polymorphisme génétique de l’UGT1A1 en première ligne de traitement du cancer colorectal métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study: individualization of dosage of irinotecan in the FOLFIRI according to the genetic polymorphism of UGT1A1 in the first line treatment of metastatic colorectal cancer
    Etude de phase II : individualisation de la posologie d'irinotécan dans le protocole FOLFIRI selon le polymorphisme génétique de l’UGT1A1 en première ligne de traitement du cancer colorectal métastatique
    A.3.2Name or abbreviated title of the trial where available
    IriGen
    A.4.1Sponsor's protocol code numberIriGen
    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 SponsorCentre Jean Perrin
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderCampto 100 mg/5mL
    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 nameIrinotecan
    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.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
    first line metastatic colorectal cancer
    cancer colorectal métastatique première ligne
    E.1.1.1Medical condition in easily understood language
    none
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    Assess the interest in terms of toxicity and response individualizing dosage of irinotecan according polymorphism UGT1A1
    Evaluer l’intérêt en termes de toxicités et de réponse de l’individualisation de la posologie d’irinotécan selon le polymorphisme de l’UGT1A1
    E.2.2Secondary objectives of the trial
    -Study of the pharmacokinetics of irinotecan, the SN38 and SN38-G, and bevacizumab
    -Evaluation of the effectiveness of treatment (progression-free survival, duration of response)
    -Etude de la pharmacocinétique de l’irinotécan, du SN38 et du SN38-G, ainsi que du bevacizumab
    -Evaluation de l’efficacité du traitement (survie sans progression, durée de la réponse)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Colorectal cancer histologically or cytologically proven
    - Indication of treatment according to the FOLFIRI + / - bevacizumab
    - Age> 18 years
    - Presence of at least one measurable target by RECIST
    - Life expectancy> 3 months
    - Satisfactory biological functions (renal, hepatic and hematologic)
    - Cancer colorectal prouvé histologiquement ou cytologiquement
    - Indication de traitement selon le protocole FOLFIRI +/- bevacizumab
    - Age > 18 ans
    - Présence d’au moins une cible mesurable selon les critères RECIST
    - Espérance de vie > 3 mois
    - Fonctions biologiques satisfaisantes (rénale, hépatique et hématologique)
    E.4Principal exclusion criteria
    - Patients of childbearing age and not using effective contraception and patient pregnant or nursing
    - Patient with another pathology deemed incompatible with the entry in the protocol
    - Prior treatment in metastatic
    - Patients taking antiepileptic
    - Allergic reaction or intolerance to irinotecan
    - Heart failure, kidney, bone marrow, liver or respiratory
    - Significant psychiatric or neurological abnormality
    - Infectious syndrome requiring treatment with antibiotics or antiviral long-term
    - Against Heart indication 5-FU
    - Concurrent treatment with a drug test, participation in a clinical trial within <30 days
    - Patient en âge de procréer et n’utilisant pas de contraception efficace et patiente enceinte ou allaitant
    - Patient présentant une autre pathologie jugée comme incompatible avec l’entrée dans le protocole
    - Traitement antérieur au stade métastatique
    - Patient prenant des antiépileptiques
    - Réaction allergique ou intolérance à l’irinotécan
    - Insuffisance cardiaque, rénale, médullaire, respiratoire ou hépatique
    - Anomalie neurologique ou psychiatrique significative
    - Syndrome infectieux nécessitant un traitement antibiotique ou antiviral à long terme
    - Contre indication cardiaque au 5-FU
    - Traitement concomitant par un médicament en essai, participation à un essai thérapeutique dans un délai < 30 jours
    E.5 End points
    E.5.1Primary end point(s)
    - The frequency of occurrence of severe toxicities of grade 4 neutropenia, febrile neutropenia, grade 4 diarrhea
    Toxicities will be graded according to NCI-CTC scoring, version 4.0 throughout the treatment. Toxicities are therefore identified in each course.
    - The response rate of patients with partial response or complete response to the number of patients (ITT).
    The response to treatment will be assessed according to RECIST version 1.1 criteria.
    - La fréquence d’apparition des toxicités sévères : neutropénies de grade 4, neutropénie fébrile, diarrhée de grade 4
    Les toxicités seront gradées selon la cotation NCI-CTC, version 4.0 tout au long du traitement. Les toxicités seront donc relevées lors de chaque cure.
    - Le taux de réponse : nombre de patients en réponse partielle ou en réponse complète sur le nombre de patients inclus (ITT).
    La réponse au traitement sera évaluée selon les critères RECIST version 1.1.
    E.5.2Secondary end point(s)
    - Pharmacokinetics of irinotecan, the SN38, the SN38-G, bevacizumab:
    Measurements of the plasma concentration and AUC will be made ​​using a specific analysis, liquid chromatography coupled to a mass spectrometer technique.
    - Evaluation of overall survival and progression-free survival.
    - Pharmacocinétique de l’irinotécan, du SN38, du SN38-G, du bevacizumab :
    Les dosages de la concentration plasmatique et de l’AUC seront réalisés à l’aide d’une technique d’analyse spécifique, la chromatographie en phase liquide couplée à un spectromètre de masse.
    - Evaluation de la survie globale et la survie sans progression.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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.8.2 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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    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 test is at the end of follow-up of the last patient included.
    La fin de l'essai se situe à la fin du suivi du dernier patient inclus.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state47
    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
    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 Decision2013-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-09
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