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    Summary
    EudraCT Number:2014-001263-12
    Sponsor's Protocol Code Number:FoRT01/2014
    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:2014-06-23
    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 number2014-001263-12
    A.3Full title of the trial
    Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation (METROS)
    Crizotinib nel tumore pretrattato al polmone non a piccole cellule con amplificazione MET o traslocazione ROS1 (METROS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation (METROS)
    Crizotinib nel tumore pretrattato al polmone non a piccole cellule con amplificazione MET o traslocazione ROS1 (METROS)
    A.3.2Name or abbreviated title of the trial where available
    METROS
    METROS
    A.4.1Sponsor's protocol code numberFoRT01/2014
    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 SponsorFondazione Ricerca Traslazionale (FoRT)
    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 supportPfizer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Ricerca Traslazionale (FoRT)
    B.5.2Functional name of contact pointFondazione Ricerca Traslazionale
    B.5.3 Address:
    B.5.3.1Street AddressVia Magnagrecia 30/a
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00183
    B.5.3.4CountryItaly
    B.5.4Telephone number+390586370465
    B.5.5Fax number+390586370465
    B.5.6E-mailf.cappuzzo@googlemail.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 XALKORI 250 mg hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCRIZOTINIB
    D.3.2Product code PF-02341066
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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: 2
    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 XALKORI 200 mg capsule hard
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCRIZOTINIB
    D.3.2Product code PF-02341066
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    Pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation
    Tumore pretrattato al polmone non a piccole cellule con amplificazione MET o traslocazione ROS
    E.1.1.1Medical condition in easily understood language
    Pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation
    Tumore pretrattato al polmone non a piccole cellule con amplificazione MET o traslocazione ROS
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    To assess the efficacy and safety and tolerability of Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation
    Valutare l’efficacia, la sicurezza e la tollerabilità del Crizotinib nel tumore pretrattato al polmone non a piccole cellule con amplificazione MET o traslocazione ROS1
    E.2.2Secondary objectives of the trial
    Not applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed diagnosis of NSCLC
    • Availability of tumor tissue for ROS1, and MET analyses
    • Patient positive for ROS1 translocation or MET amplification
    • Radiological measurable disease according to RECIST criteria
    • At least 1 previous standard chemotherapy regimen
    • Performance status 0-2 (ECOG)
    • Patient compliance to trial procedures
    • Age ≥ 18 years
    • Written informed consent
    • Diagnosi di NSCLC confermata istologicamente
    • Disponibilità di tessuto tumorale per le analisi di ROS1 e MET
    • Paziente positivo per la traslocazione ROS1 o per l’amplificazione MET
    • Malattia misurabile radiologicamente in accordo ai criteri RECIST
    • Almeno 1 regime precedente di chemioterapia standard
    • Performance status 0-2 (ECOG)
    • Compliance del paziente alle procedure cliniche
    • Età ≥ 18 anni
    • Consenso informato scritto
    E.4Principal exclusion criteria
    • No tumor tissue available or patient negative for ROS1 translocation or MET amplification
    • Absence of any measurable lesions
    • For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agents
    • For MET amplified patients: Evidence of MET amplification in tumor tissue collected in EGFR mutant patient at time of EGFR-TKI acquired resistance occurrence. An EGFR mutant patient is eligible if MET amplification is detected in a tumor specimen collected before starting an EGFR-TKI
    • No previous chemotherapy
    • Concomitant radiotherapy or chemotherapy
    • Symptomatic brain metastases
    • Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma
    • Pregnancy or lactating
    ancata disponibilità di tessuto tumorale o paziente negativo alla traslocazione ROS1 o all’amplificazione MET
    • Assenza di qualsiasi lesione misurabile
    • Per i pazienti ROS1: terapia precedente con crizotinib o qualsiasi agente anti- ALK
    • Per i pazienti MET amplificati: evidenza di amplificazione MET in tessuto tumorale prelevato da pazienti EGFR mutati al momento del verificarsi della resistenza acquisita all’EGFR-TKI. Un paziente EGFR mutato è eleggibile se l’amplificazione MET è rilevata in un campione tumorale prelevato prima di iniziare un EGFR-TKI
    • Nessuna chemioterapia precedente
    • Radioterapia o chemioterapia concomitante
    • Metastasi cerebrali sintomatiche
    • Diagnosi di qualsiasi altro tumore maligno durante gli ultimi cinque anni, eccetto per il carcinoma in situ della cervice uterina e per il carcinoma della pelle a cellule squamose
    • Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary:
    • Response rate to crizotinib in patients with ROS1 translocation or MET amplification

    Co-primario:
    • Tasso di risposta al crizotinib in pazienti con traslocazione ROS1 o amplificazione MET


    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    • Sopravvivenza libera da progressione (PFS)
    • Sopravvivenza globale (OS)
    • Tossicità
    • Correlazione con biomarkers tumorali addizionali in tessuti tumorali o nel sangue
    • Risposta in accordo con i diversi livelli di traslocazione ROS1 o amplificazione MET (ratio>2.2 e <5 contro ratio ≥5)
    • Progression-free survival (PFS)
    • Overall Survival (OS)
    • Toxicity
    • Correlation with additional tumor biomarkers in tumor tissue or blood
    • Response according to different levels of ROS1 translocation or MET amplification (ratio >2.2 and <5 versus ratio ≥ 5)
    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 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 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) Information not present in EudraCT
    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 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 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
    LVLS
    LVLS
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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
    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 Decision2014-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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