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    Summary
    EudraCT Number:2012-000834-21
    Sponsor's Protocol Code Number:POCHER-2/AIRC11770
    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:2012-04-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000834-21
    A.3Full title of the trial
    Molecular Biomarkers for Colorectal Liver Metastases Resectability after Chemotherapy with Cetuximab
    MARCATORI BIOMOLECOLARI DI RESECABILITA' PER METASTASI EPATICHE COLORETTALI TRATTATE CON CHEMIOTERAPIA PIU' CETUXIMAB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tumour markers response to chemotherapy in patients with colorectal liver metastases
    Marcatori di risposta alla chemioterapia in pazienti con metastasi epatiche colorettali
    A.3.2Name or abbreviated title of the trial where available
    POCHER-2
    POCHER-2
    A.4.1Sponsor's protocol code numberPOCHER-2/AIRC11770
    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 SponsorISTITUTI FISIOTERAPICI OSPITALIERI
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO REGINA ELENA
    B.5.2Functional name of contact pointONCOLOGIA MEDICA A
    B.5.3 Address:
    B.5.3.1Street AddressVIA ELIO CHIANESI 53
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.4Telephone number06-52666919
    B.5.6E-mailgarufi@ifo.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*INFUS 1FL 50ML 5MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO SpA
    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.3.4Pharmaceutical form Powder and solvent 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.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2
    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) Yes
    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
    PATIENTS WITH LIVER COLORECTAL METASTASES NOT CANDIDATED TO SURGERY
    PAZIENTI CON METASTASI EPATICHE COLORETTALI NON SUSCETTIBILI DI CHIRURGIA
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH LIVER METASTASES NOT CANDIDATED TO SURGERY
    PAZIENTI CON METASTASI EPATICHE NON OPERABILI
    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 10024700
    E.1.2Term Liver metastases
    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
    COMPLETE LIVER RESECTION AFTER CHEMOTHERAPY
    1. Percentuale di resezioni epatiche complete
    E.2.2Secondary objectives of the trial
    TIME TO SURGERY
    TIME TO PROGRESSION
    TOLERABILITY
    RESPONSE RATE
    OVERALL SURVIVAL
    End-points secondari clinici
    1. Tempo alla chirurgia
    2. Tempo alla progressione di malattia
    3. Tollerabilità delle combinazioni
    4. Riesponse rate calcolata secondo i criteri RECIST ( )
    5. Overall survival
    III. End-points secondari biologici
    1. Ruolo delle mutazioni della pathway di EGFR
    2. Ruolo dell’espressione dei clock-genes
    3. Ruolo dei polimorfismi
    4. Ruolo delle mutazioni di p53 e mismatch repair
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    COLORECTAL LIVER METASTASES
    UNRESECTABLE ACCORDING TO NORTLINGER CLASSIFCIATION (ANN.ONCOL.2009)
    1. Adenocarcinoma del colon-retto istologicamente accertato, k-ras wild type.
    2. Tumore primitivo asportato o in sede
    3. Metastasi epatiche colorettali da adenocarcinoma del colon retto. I pazienti saranno stratificati prima della randomizzazione tra Gruppo B e Gruppo C secondo Nordlinger. I pazienti del gruppo B, ovvero i cosiddetti “Not optimally resectable” saranno suddivisi in pazienti non resecabili per motivi oncologici o per motivi tecnici.
    Gruppo B: “non optimally resectable”: Motivi Oncologici ( almeno 2 fattori)
    • &gt;4 metastasi
    • Dimensioni &gt;5 cm
    • Metastasi sincrone
    • Stadio III (N+) sul tumore primitivo
    • Marker tumorali (CEA e CA19-9 aumentati)
    Gruppo B: “non optimally resectable”: Motivi Chirurgici “ tecnicamente difficile”
     vicino alle vene sovraepatiche
     vicino ad entrambi i rami portali
     Necessità di eseguire una resezione epatica che risparmi &lt;30% del parenchima epatico
    Gruppo C:
    I pazienti del Gruppo C di Nordlinger sono considerati quelli non resecabili e molto probabilmente mai candidati a chirurgia. Si tratta di pazienti con malattia estesa a tutto il fegato.

    4. Età ≥ 18 anni and ≤ 70 anni.
    5. PS secondo ECOG: 0-1
    6. Aspettative di vita ≥3 mesi
    7. Dati di Laboratorio:
     Neutrofili ≥ 1.5 x 109/L, piastrine ≥ 100 x 109/L, Hb ≥ 9 g/dl, ALAT e ASAT ≤ 2.5 x ULN,
     Bilirubina Totale ≤ 1.5 x ULN, Creatinina Clearance ≥ 60 ml/min (calcolata con la formula)
    8. Misure di contraccezione efficaci nelle pazienti a rischio di gravidanza
    9. Assenza di controindicazioni ai farmaci utilizzati
    10. Consenso Informato
    E.4Principal exclusion criteria
    EXTENSION OF DISEASE OUTSIDE THE LIVER
    1. Metastasi extra-epatiche ad eccezione di interessamento polmonare minimo (≤ metastasi di diametro max ≤ 2.0 cm o ≤ 6 metastasi diametro max ≤ 1.0 cm).
    2. Precedente trattamento chemioterapico per la malattia metastatica con chemioterapia, Ab monoclonali o entrambi.
    3. Cardiopatia ischemica in trattamento o infarto del miocardio nei 12 mesi precedenti l’inclusione nello studio.
    4. Occlusione intestinale o subocclusione per motivi legati alla malattia neoplastica
    5. Multiple resezioni intestinali in pazienti sottoposti a RT sulla pelvi per neoplasia rettale
    6. Pregressa allergia all’oxaliplatino
    7. Malattie psichiche o incapacità mentali tali da non poter acconsentire al condenso informato
    8. Difficoltà logistiche tali da non assicurare un eventuale ricovero in ospedale se necessario
    9. Seconde neoplasie ad eccezione di neoplasie maligne non-melanoma della cute, carcinoma in situ della cervice.
    E.5 End points
    E.5.1Primary end point(s)
    COMPLETE RESECTION OF LIVER METASTASES
    1. Percentuale di resezioni epatiche complete
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 MONTHS
    4 MESI
    E.5.2Secondary end point(s)
    TIME TO PROGRESSION
    TEMPO ALLA PROGRESSIONE
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 MONTHS
    24 MESI
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 trial2
    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 concerned14
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state300
    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)
    according to clinical practice
    secondo 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 Decision2012-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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