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    Summary
    EudraCT Number:2019-002115-26
    Sponsor's Protocol Code Number:FBH-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-05
    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 number2019-002115-26
    A.3Full title of the trial
    Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study
    Cetuximab chez des patients atteints d'un cancer colorectal métastatique prétraité après perte de mutation du gène KRAS ou NRAS - Etude de preuve de concept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study
    A.3.2Name or abbreviated title of the trial where available
    CETIDYL
    A.4.1Sponsor's protocol code numberFBH-001
    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 SponsorInstitut Hospitalier Franco-Britanique
    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 supportFondation ARCAD
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Foch
    B.5.2Functional name of contact pointIsabelle Buffet
    B.5.3 Address:
    B.5.3.1Street Address40 rue Worth - BP 36
    B.5.3.2Town/ citySuresnes
    B.5.3.3Post code92151
    B.5.3.4CountryFrance
    B.5.4Telephone number331 46 25 37 48
    B.5.5Fax number331 46 25 27 66
    B.5.6E-maili.buffet@hopital-foch.com
    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 Erbitex
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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 nameCetuximab
    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 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 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
    colorectal cancer
    Cancer colorectal
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    ancer colorectal
    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
    To evaluate the efficacy (response rate using RECIST 1.1) of cetuximab with (cohort #2) or without (cohort #1) irinotecan in patients with neo wild-type metastatic colorectal cancer
    Evaluer le taux de réponse en utilisant les critères RECIST v1.1
    E.2.2Secondary objectives of the trial
    - To evaluate progression-free survival (PFS),
    - To evaluate overall survival (OS)
    - To evaluate disease control rate (DCR)
    - To evaluate safety
    - Evaluer la survie sans progression (PFS)
    - Evaluer la survie globale (OS)
    - Evaluer le taux de contrôle de la maladie (DCR)
    - Evaluer la tolérance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent and stated willingness to comply with all study procedures and availability for the duration of the study,
    2. Male or female subjects, ≥18 years of age,
    3. ECOG performance status (ECOG PS, Appendix 15.1) ≤2,
    4. Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer,
    5. At least one (≥1) measurable and/or evaluable liver metastasis,
    6. Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin, irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept),
    7. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
    - Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
    - Adequate renal function: serum creatinine clearance (MDRD) ≥ 50 mL/min/1,73 m2
    - Adequate liver function: serum bilirubin ≤1.5x upper normal limit (ULN), alkaline phosphatase <5xULN, AST and ALT ≤5xULN,
    - Adequate serum electrolyte levels (magnesium, potassium, calcium) prior to initiation of study treatment,
    8. Negative pregnancy test within 7 days prior to initiation of the study drug for female patients of childbearing potential,
    9. Effective contraception for both male and female subjects if the risk of conception exists
    10. Registration in a national health care system.
    1) Formulaire de consentement éclairé daté et signé, volonté déclarée de se conformer à toutes les procédures de l’étude et disponible pour la durée de l’étude
    2) Homme ou femme âgé(e) de plus de 18 ans
    3) Statut de performance ECOG 0 à 2
    4) Cancer colorectal métastasique non résécable RAS muté (mutation du gène tumoral KRAS ou NRAS)
    5) Au moins 1 (≥ 1) métastase hépatique mesurable,
    6) Traitement préalable (résistant ou intolérant) avec des fluoropyrimidines, l’oxaliplatine, l’irinotecan et un agent anti-angiogénique (c’est-à-dire bevacizumab et/ou afflibercept)
    7) Fonctions vitales et hématologique adéquates définies par les résultats des tests de laboratoire suivants, obtenus dans les 14 jours avant la mise sous traitement :
    - Statut hématologique : neutrophiles (PNN) ≥1.5x109/L ; plaquettes ≥100x109/L ; hémoglobine ≥ 9.0g/dL
    - Fonction rénale adéquate : clairance de la créatinine sérique (MDRD) ≥ 50 mL/min
    - Fonction hépatique adéquate : bilirubine sérique ≤ 1.5x limite normale supérieure, phosphatases alcalines<5x LNS, ASAT et ALAT ≤5x LNS
    - Niveaux adéquats d’électrolytes sériques avant la mise sous traitement
    8) Pour les femmes en âge de procréer, test de grossesse négatif dans les 7 jours précédant la mise sous traitement
    9) Pour les hommes et les femmes en âge de procréer, utilisation d’un moyen de contraception efficace
    10) Affilié à un régime d’Assurance Maladie
    E.4Principal exclusion criteria
    1. Known allergy or hypersensitivity reactions to any study drug,
    2. Women who are pregnant or breastfeeding,
    3. Inability to comply with study and follow-up procedures as judged by the Investigator,
    4. Patient with BRAF mutant colorectal cancer
    5. History of interstitial lung disease
    6. Treatment with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort for patients of cohort #2
    7. Treatment with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) for patients of cohort #2
    8. Treatment with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) for patients of cohort # 2
    9. Patients of cohort #2 with known UGT1A deficiency
    10. Uncontrolled illness, including but not limited to ongoing bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination/ clinical laboratory finding that leads to a reasonable suspicion of a disease/condition that contraindicates the use of any of investigational drugs that may affect the interpretation of the results, or that may render the subject at high risk of treatment complications.
    11. Patient with current intestinal obstruction or history of chronic inflammatory bowel disease
    1) Réactions allergiques ou hypersensibilité connues aux traitements à l’étude
    2) Femmes enceintes ou allaitantes
    3) Incapacité de se conformer à l’étude et aux procédures de suivi, selon l’avis de l’investigateur
    4) Patient avec tumeur BRAF V600E mutée
    5) Antécédent de maladie interstitielle pulmonaire
    6) Traitement avec de puissants inducteurs de l’enzyme CYP3A4, tels que les anticonvulsivants (phénytoïne, phénobarbital ou carbamazépine), la rifampicine, la rifabutine et le millepertuis
    7) Traitement avec de puissants inhibiteurs de l’enzyme CYP3A4 (par exemple jus de pamplemousse, clarithromycine, indinavir, itraconazole, lopinavir, néfazodone, nelfinavir, ritonavir, saquinavir, télaprévir, voriconazole)
    8) Traitement avec de puissants inhibiteurs de l’UGT1A (par exemple atazanavir, gemfibrozil, indinavir) chez les patients de la cohorte 2
    9) Patients de la cohorte 2 présentant un déficit connu en UGT1A
    10) Toute maladie non contrôlée, incluant mais non limité aux infections bactériennes, virales ou fongiques nécessitant un traitement systémique, un dysfonctionnement métabolique, un résultat d’un examen physique ou de laboratoire indiquant une suspicion de maladie et/ou condition qui contre-indique l’utilisation des traitements à l’étude qui peuvent altérer l’interprétation des résultats, ou qui peuvent rendre le patient à haut risque de complications de traitement.
    11) Patient avec une occlusion intestinale ou des antécédents de maladie inflammatoire chronique de l’intestin
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is response rate.
    Taux de réponse (Réponse Complète + Réponse Partielle) en utilisant RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment evaluation visit
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    - PFS is defined as the time from the date of starting treatment to the date of progression or death (from any cause). Patients alive without documented objective PD at the time of the final analysis will be censored at the date of their last objective tumor assessment.
    - OS is defined as the time from the date of starting treatment to the date of patient death (from any cause) or to the last date the patient was known to be alive. Patients still alive at the time of the analysis will be censored using the date of last news.
    - Disease control rate (DCR) is defined as the percentage of patients achieving CR, PR, or stable disease (SD).

    Secondary safety endpoints are:
    - Toxicity will be evaluated according to the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    date of progression or date of patient death
    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 No
    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 concerned2
    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 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
    Follow-up period will continue until death. Patients withdrawn from the study treatment due to any AEs will be followed at least until the outcome is determined, even if it implies that the follow up continues after the patients has left the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    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 Decision2019-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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