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    Summary
    EudraCT Number:2020-003008-15
    Sponsor's Protocol Code Number:CAPRI2
    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:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003008-15
    A.3Full title of the trial
    CAPRI 2 GOIM study: investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
    Studio CAPRI 2 GOIM: studio sull’efficacia e la sicurezza del regime di trattamento basato su cetuximab e guidato da biomarcatori su 3 linee di trattamento in pazienti affetti da carcinoma del colonretto metastatico che presentano uno stato Wild Type di RAS e BRAF prima dell’inizio del trattamento di prima linea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CAPRI 2 GOIM study: investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
    Studio CAPRI 2 GOIM: studio sull’efficacia e la sicurezza del regime di trattamento basato su cetuximab e guidato da biomarcatori su 3 linee di trattamento in pazienti affetti da carcinoma del colonretto metastatico che presentano uno stato Wild Type di RAS e BRAF prima dell’inizio del trattamento di prima linea
    A.3.2Name or abbreviated title of the trial where available
    CAPRI 2
    CAPRI 2
    A.4.1Sponsor's protocol code numberCAPRI2
    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 SponsorGRUPPO ONCOLOGICO DELL'ITALIA MERIDIONALE
    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 supportMerck Serono S.p.A.,
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical research Technology
    B.5.2Functional name of contact pointClinical Operations and Regulatory
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo trav Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39089301545
    B.5.5Fax number+390897724155
    B.5.6E-mailcapri2@cr-technology.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 ERBITUX - 5 MG/ML SOLUZIONE PER INFUSIONE - USO ENDOVENOSO- FLACONCINO(VETRO) 20 ML 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK KGAA
    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
    D.3.2Product code [EMD271786]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.2Current sponsor codecetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    mCRC patients with RAS/BRAF wild type tumors at start of first line treatment
    Pazienti affetti da carcinoma del colonretto metastatico che presentano uno stato Wild Type di RAS e BRAF prima dell’inizio del trattamento di prima linea
    E.1.1.1Medical condition in easily understood language
    mCRC patients with RAS/BRAF wild type tumors at start of first line treatment
    Pazienti affetti da carcinoma del colonretto metastatico che presentano uno stato Wild Type di RAS e BRAF prima dell’inizio del trattamento di prima linea
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    Response Rate (RR) per each line of therapy: assessed according to RECIST criteria 1.1
    Tasso di Risposta (RR): valutato secondo i criteri RECIST 1.1 per ogni linea di trattamento
    E.2.2Secondary objectives of the trial
    - Progression Free Survival (PFS) per each line of therapy
    - Overall Survival (OS)
    - Safety
    - Sopravvivenza libera da progressione di malattia per ogni linea di trattamento (Progression Free Survival-PFS)
    - Sopravvivenza complessiva (Overall Survival- OS)
    - Profilo di sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of colorectal adenocarcinoma
    2. Diagnosis of metastatic disease
    3. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
    4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1)
    5. Male or female patients = 18 years of age
    6. ECOG Performance Status 0,1
    7. Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment
    8. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of
    7 days before initiation of study treatment
    9. If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence,
    intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
    10. Signed informed consent obtained before screening.
    1. Conferma istologica della diagnosi di adenocarcinoma del colon-retto
    2. Diagnosi di malattia metastatica
    3. Status WT di RAS e BRAF verificato tramite analisi di un campione di tessuto tumorale primario e/o relative metastasi fissato in paraffina (FFPE)
    4. Malattia misurabile secondo i criteri RECIST 1.1
    5. Pazienti di entrambi i sessi con almeno 18 anni di età
    6. ECOG Performance Status uguale a 0 o 1
    7. Adeguata funzione del midollo osseo, del fegato e del rene al basale valutate entro i 14 giorni precedenti l’inizio del trattamento di studio
    8. In caso di donne potenzialmente fertili, risultato negativo del test di gravidanza effettuato al massimo 7 giorni prima
    dell’inizio del trattamento di studio
    9. In caso di donne e uomini potenzialmente fertili, consenso all’uso di un adeguato metodo contraccettivo (per esempio
    astinenza sessuale, dispositivo intrauterino, contraccettivo orale o metodo a doppia barriera) durante lo studio e fino ad
    almeno 3 mesi dopo l’ultima assunzione di farmaco sperimentale, sulla base del giudizio dello sperimentatore
    10. Consenso informato firmato ottenuto prima dello screening
    E.4Principal exclusion criteria
    1. Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid, bevacizumab, trifluridine-tipiracil, regorafenib
    2. Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
    3. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
    4. Pregnancy (exclusion to be ascertained by a beta hCG test)
    5. Breastfeeding
    6. Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•
    7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
    8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
    9. Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
    10. Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
    11. Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
    12. Known or clinically suspected brain metastases
    13. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
    14. Severe, non-healing wounds, ulcers or bone fractures
    15. Uncontrolled hypertension
    16. Marked proteinuria (nephrotic syndrome)
    17. Known DPD deficiency (specific screening not required)
    18. Known history of alcohol or drug abuse
    19. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
    20. Absent or restricted legal capacity
    1. Qualsiasi controindicazione all’utilizzo di cetuximab,
    irinotecan, 5-FU, oxaliplatino, acido folinico, bevacizumab,
    trifluridina-tipiracile, regorafenib
    2. Infezioni attive non trattate, coagulazione intravascolare
    disseminata o storia di malattia polmonare interstiziale
    3. Precedenti o concomitanti neoplasie oltre il carcinoma del
    colon-retto, fatta eccezione per carcinoma della pelle a cellule
    squamose o basali o carcinoma in situ della cervice trattati e
    curati
    4. Gravidanza (dovrà essere accertata tramite test beta hCG)
    5. Donne in fase di allattamento
    6. Donne potenzialmente fertili (meno di due anni dall’ultima
    mestruazione) e uomini potenzialmente fertili non
    intenzionati ad usare un efficiente metodo contraccettivo
    7. Infarto miocardico, angina pectoris instabile, PTCA con o
    senza stenting entro i 12 mesi precedenti all’inclusione nello
    studio, insufficienza cardiaca di grado III o IV (in accordo
    con la classificazione NYHA)
    8. Aritmia cardiaca che richiede una terapia antiaritmica, fatta
    eccezione per beta bloccanti o digossina
    9. Qualsiasi impedimento di tipo medico o psicologico che
    potrebbe interferire con la capacità del soggetto di dare il
    consenso alla partecipazione allo studio o che non permetta
    la conduzione dello studio
    10. Precedente chemioterapia per il carcinoma del colon-retto
    fatta eccezione per i trattamenti adiuvanti completati almeno
    6 mesi prima l’entrata del paziente nello studio
    11. Partecipazione ad un altro studio clinico o assunzione di un
    farmaco sperimentale entro i 30 giorni precedenti
    l’inclusione nello studio o durante la partecipazione allo
    studio
    12. Evidenza o sospetto clinico di metastasi al cervello
    13. Storia medica di occlusione intestinale acuta o subacuta,
    malattia cronica infiammatoria intestinale o diarrea cronica
    14. Ferite gravi, non cicatrizzate, ulcere o fratture ossee
    15. Ipertensione non trattata
    16. Proteinuria marcata (sindrome nefrosica)
    17. Evidenza di deficienza di DPD (non è richiesto uno screening
    specifico)
    18. Storia di abuso di alcol o droghe
    19. Presenza di una qualsiasi malattia concomitante che a
    giudizio dello sperimentatore possa interferire con la
    partecipazione del paziente nello studio
    20. Capacità giuridica assente o limitata
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate (RR) per each line of therapy assessed according to RECIST criteria 1.1
    Tasso di Risposta (RR): valutato secondo i criteri RECIST 1.1 per ogni linea di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 8, 16 and 24 months
    A 8, 16 e 24 mesi
    E.5.2Secondary end point(s)
    - Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause.
    - Overall Survival (OS): calculated from the start of the study treatment until death.
    - Safety: Adverse events graded according NCI CTCAE v 5.0.
    - Sopravvivenza libera da progressione di malattia per ogni linea di trattamento (Progression Free Survival-PFS) definita come tempo dall'assegnaizone del trattamento alla progressione di malattia o decesso per qualsiasi causa per ogni linea di trattamento
    - Sopravvivenza complessiva (Overall Survival-OS)
    - Profilo di sicurezza: eventi avversi valutati secondo NCI CTCAE v 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At 8, 16 and 24 months
    - From the start of the study treatment until death.
    - Throughout the study duration
    - A 8, 16 e 24 mesi
    - Dall'inizio del trattamento al decesso per qualsiasi causa
    - Durante l'intera durata dello studio
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned25
    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 Information not present in EudraCT
    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 study will end 2 years after the last patient receives the last dose of treatment, when the survival FU period will be ended.
    Lo studio terminerà 2 anni dopo l'ultima somministraizone di farmaco all'ultimo paziente, quando terminerà l'osservaizone della survival FU.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject incapable of giving consent for physical reasons or reason linked to
    their medical condition
    Soggetto incapace di dare il consenso per motivi fisici o motivi legati alla
    loro condizione medica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    At the end of the treatment phase, survival follow-up will continue for up to 2 years after the last dose. The patient will receive other anticancer treatments both experimental and from clinical practice.
    Al termine della fase di trattamento il follow-up sulla sopravvivenza continuerà fino a 2 anni dall'ultima dose. Il paziente potrà ricevere altri trattamenti antitumorali sia sperimentali che da 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 Decision2021-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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