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    Summary
    EudraCT Number:2018-003778-29
    Sponsor's Protocol Code Number:CIFRA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003778-29
    A.3Full title of the trial
    Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V
    Studio di fase II sull’utilizzo dell’associazione FOLFIRI+Cetuximab nel trattamento di prima linea dei pazienti affetti da carcinoma del colon-retto avanzato con RAS wild type e FcYRIIIA-V/V
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V
    Studio di fase II sull’utilizzo dell’associazione FOLFIRI+Cetuximab nel trattamento di prima linea dei pazienti affetti da carcinoma del colon-retto avanzato con RAS wild type e FcYRIIIA-V/V
    A.3.2Name or abbreviated title of the trial where available
    CIFRA
    CIFRA
    A.4.1Sponsor's protocol code numberCIFRA
    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 SponsorIstituto Nazionale Tumori G. Pascale
    B.1.3.4CountryItaly
    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 supportIstituto Nazionale Tumori G. Pascale
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale Tumori G. Pascale
    B.5.2Functional name of contact pointAlessandro Ottaiano
    B.5.3 Address:
    B.5.3.1Street Addressvia Mariano Semmola,snc
    B.5.3.2Town/ cityNaples
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone numberItaly0815903367
    B.5.5Fax numberItaly0813606259
    B.5.6E-maila.ottaiano@istitutotumori.na.it
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMERK
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameErbitux - Cetuximab
    D.3.4Pharmaceutical form Emulsion 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.IMP: 2
    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 Campto - Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.IMP: 3
    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 Fluorouracile Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFluorouracile
    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: 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 Lederfolin – Acido Folico
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameLederfolin
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    Intravenous 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
    advanced colorectal carcinoma with wild type RAS and FcyRIIIA-V / V
    carcinoma del colon-retto avanzato con RAS wild type e FcyRIIIA-V/V
    E.1.1.1Medical condition in easily understood language
    advanced colorectal carcinoma / V
    carcinoma del colon-retto avanzato
    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
    Main objective: The aim of the present study is to evaluate the activity of the Cetuximab, Irinotecan and Fluorouracil association in patients with metastatic colorectal cancer selected through the study of RAS and of the genetic polymorphism of the FcγRIIIa V / V
    Obiettivo principale: Lo scopo del presente studio è valutare l’attività dell’associazione Cetuximab, Irinotecan e Fluorouracile in pazienti affetti da cancro del colon-retto metastatico selezionati attraverso lo studio del RAS e del polimorfismo genetico dell’FcγRIIIa V/V
    E.2.2Secondary objectives of the trial
    Secondary objectives: Describe the duration of the response, the progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
    Obiettivi secondari: Descrivere la durata della risposta, la sopravvivenza libera da progressione (Progressione-Free Survival, PFS) e la sopravvivenza (Overall Survival, OS). Valutare la presenza di macrofagi M1/M2 nel microambiente tumorale e correlarla con la risposta alla terapia. Valutare la tossicità che sarà misurata con Common Terminology Criteria for Adverse Events (CTCAE) versione 3.0.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Cytological or histological diagnosis of colorectal adenocarcinoma
    • wild-type RAS
    • FcγRIIIa-158V / V genotype
    • Stage IV
    • Negative pregnancy test where applicable
    • Age <75 years
    • At least 1 lesion measurable according to the RECIST criteria v1.1
    • ECOG Performance Status 0 or 1
    • Life expectancy> 3 months
    • Written informed consent
    • Diagnosi citologica o istologica di adenocarcinoma del colon-retto
    • RAS wild-type
    • Genotipo FcγRIIIa-158V/V
    • Stadio IV
    • Test di gravidanza negativo ove applicabile
    • Età < 75 anni
    • Almeno 1 lesione misurabile secondo i criteri RECIST v1.1
    • Performance Status ECOG 0 o 1
    • Aspettativa di vita >3 mesi
    • Consenso informato scritto
    E.4Principal exclusion criteria
    • Previous systemic anti-tumor treatment; allowed treatment with Capecitabine or fluorouraciol and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated for at least 6 months.
    • Presence of primary non-treated stenosing colorectal neoplasm with endoprosthesis positioning
    • Neutrophils <2000 / mm³ or platelets <100,000 / mm³ or hemoglobin <9 g / dl
    • Creatinineemia> 1.5 times the maximum normal value
    • GOT and / or GPT> 5 times the maximum normal value and / or bilirubinemia> 3 times the maximum normal value
    • Previous malignant neoplasm (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
    • Infection in active or uncontrolled phase
    • Other concomitant disorders that are decompensated or uncontrolled or that contraindicate the study drugs at the judgment of the clinician
    • Presence of brain metastases
    • Refusal or inability to provide informed consent
    • Impossibility to guarantee follow-up
    • Precedente trattamento anti-tumorale sistemico; consentito trattamento con Capecitabina o fluorouraciule e radioterapia nel setting neoadiuvante dei tumori del retto con terapia terminata da almeno 6 mesi.
    • Presenza di neoplasia primitiva del colon-retto stenosante non trattata con posizionamento di endoprotesi
    • Neutrofili < 2000/mm³ o piastrine < 100.000/mm³ o emoglobina < 9 g/dl
    • Creatininemia > 1.5 volte il valore massimo normale
    • GOT e/o GPT >5 volte il valore massimo normale e/o bilirubinemia >3 volte il valore massimo normale
    • Precedente neoplasia maligna (escluso il carcinoma cutaneo baso o spinocellulare o il carcinoma in situ della cervice uterina)
    • Infezione in fase attiva o non controllata
    • Altre patologie concomitanti scompensate o non controllate o che controindicano i farmaci in studio a giudizio del clinico
    • Presenza di metastasi cerebrali
    • Rifiuto o incapacità a fornire un consenso informato
    • Impossibilità a garantire il follow-up
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate if the administration of FOLFIRI / Cetuximab is active in the treatment of the 1st line of patients with metastatic colorectal cancer RAS wt and FcγRIIIA V / V. The answer will be evaluated with the RECIST v1.1.
    Valutare se la somministrazione di FOLFIRI/Cetuximab è attiva nel trattamento di I° linea di pazienti affetti da cancro del colon-retto metastatico RAS wt e FcγRIIIA V/V. La risposta sarà valutata con i RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.
    Valutazione della risposta dopo 3 mesi di terapia e successivamente ogni 3 mesi fino a progressione.
    E.5.2Secondary end point(s)
    Describe the duration of the response, progression-free survival (Progression-Free Survival, PFS) and survival (Overall Survival, OS). Evaluate the presence of M1 / M2 macrophages in the tumor microenvironment and correlate it with the response to therapy. Evaluate the toxicity that will be measured with the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
    Descrivere la durata della risposta, la sopravvivenza libera da progressione (Progressione-Free Survival, PFS) e la sopravvivenza (Overall Survival, OS). Valutare la presenza di macrofagi M1/M2 nel microambiente tumorale e correlarla con la risposta alla terapia. Valutare la tossicità che sarà misurata con Common Terminology Criteria for Adverse Events (CTCAE) versione 3.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the response after 3 months of therapy and thereafter every 3 months until progression.
    Valutazione della risposta dopo 3 mesi di terapia e successivamente ogni 3 mesi fino a progressione.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Superiority study
    Studio di superiorità
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state34
    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)
    normal clinical practice
    normale pratica clinica
    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 Decision2019-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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