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    Summary
    EudraCT Number:2013-004133-33
    Sponsor's Protocol Code Number:BO28984
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-30
    Trial results View 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 number2013-004133-33
    A.3Full title of the trial
    RANDOMIZED, MULTICENTER, PHASE III, OPEN LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT NAÏVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER
    STUDIO RANDOMIZZATO, MULTICENTRICO, DI FASE III, IN APERTO PER LA VALUTAZIONE DI ALECTINIB RISPETTO A CRIZOTINIB IN PAZIENTI NAÏVE AL TRATTAMENTO, AFFETTI DA CARCINOMA POLMONARE NON A PICCOLE CELLULE POSITIVO ALLA CHINASI DEL LINFOMA ANAPLASTICO IN STADIO AVANZATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alectinib versus crizotinib in previously untreated patients with ALK-positive non-small cell lung cancer.
    Valutazione di alectinib rispetto a crizotinib in pazienti affetti da carcinoma polmonare non a piccole cellule ALK-positivo non precedentemente trattati.
    A.4.1Sponsor's protocol code numberBO28984
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 No
    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 nameAlectinib
    D.3.2Product code RO5424802
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlectinib
    D.3.9.2Current sponsor codeRo542-4802/F03
    D.3.9.3Other descriptive nameALK INHIBITOR
    D.3.9.4EV Substance CodeSUB117669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Xalkori
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameXalkori
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrizotinib
    D.3.9.1CAS number 877399-52-5
    D.3.9.3Other descriptive nameXalkori
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Xalkori
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameXalkori
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrizotinib
    D.3.9.1CAS number 877399-52-5
    D.3.9.3Other descriptive nameXalkori
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    ALK-positive non-small cell lung cancer
    carcinoma polmonare non a piccole cellule ALK-positivo
    E.1.1.1Medical condition in easily understood language
    ALK-positive non-small cell lung cancer
    carcinoma polmonare non a piccole cellule ALK-positivo
    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
    Investigator assessed progression-free survival (PFS)
    L'obiettivo primario di efficacia dello studio è:
    valutare e confrontare l'efficacia di alectinib rispetto a crizotinib in pazienti naïve al trattamento, affetti da carcinoma polmonare non a piccole cellule (NSCLC) positivo alla chinasi del linfoma anaplastico (ALK) in stadio avanzato, misurandola in termini di sopravvivenza libera da progressione (PFS) valutata dallo sperimentatore.
    E.2.2Secondary objectives of the trial
    PFS by the IRC; time to CNS progression; Objective Response Rate (ORR) and Duration of Response (DOR); time to deterioration (TTD) in patient-reported lung cancer symptoms; health-related quality of life (HRQoL); safety and tolerability; pharmacokinetics of alectinib and metabolite(s); overall survival (OS).
    Gli obiettivi secondari di efficacia dello studio sono:
    •valutare e confrontare il tasso di risposta obiettiva (ORR) e la durata della risposta (DOR);
    •valutare e confrontare il tempo alla progressione a livello del SNC sulla base dell'esame delle radiografie eseguito da un Comitato di revisione indipendente (IRC) secondo i criteri RECIST (Response Evaluation Criteria in Solid Tumors, Criteri di valutazione della risposta nei tumori solidi) v1.1 e i criteri RANO (Revised Assessment in Neuro Oncology, Valutazione della risposta in neuro-oncologia), nonché:
    valutare il tasso di risposta obiettiva nel SNC (C-ORR) in pazienti con metastasi a livello del SNC, che presentano malattia misurabile nel SNC al basale;
    valutare la durata della risposta nel SNC (C-DOR) in pazienti che presentano una risposta obiettiva a livello del SNC;
    valutare i tassi di progressione nel SNC (C-PR) a 6, 12, 18 e 24 mesi sulla base dell'incidenza cumulativa;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at designated central laboratories.
    •Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
    •Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
    •ECOG PS of 0 2.
    •Adequate hematologic, renal and liver function.
    •Able and willing to provide written informed consent prior to performing any study related procedures and to comply with the study protocol.
    Diagnosi confermata istologicamente o citologicamente di NSCLC avanzato o ricorrente (stadio IIIB, non assoggettabile a trattamento multimodale) o metastatico (stadio IV), ALK positivo secondo la valutazione eseguita con il test Ventana IHC. È necessario un campione di tessuto tumorale sufficiente a eseguire il test ALK IHC e ALK FISH. Entrambi i test saranno eseguiti in laboratori centrali designati.
    • PS ECOG di 0-2.
    • I pazienti non devono essere stati sottoposti a trattamento sistemico precedente per l'NSCLC avanzato o ricorrente (stadio IIIB, non assoggettabile a trattamento multimodale) o metastatico (stadio IV).
    • Funzionalità ematologica, epatica e renale adeguata.
    • Malattia misurabile (secondo RECIST v1.1) prima della somministrazione del trattamento dello studio.
    E.4Principal exclusion criteria
    •Any GI disorder that may affect absorption of oral medications, such as mal absorption syndrome or status post-major bowel resection.
    •Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib or crizotinib except for oral corticosteroids up to 20 mg of prednisolone equivalent per day.
    •Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug and while on treatment.
    •History of hypersensitivity to any of the additives in the alectinib drug formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulfate [SLS], magnesium stearate).
    •History of hypersensitivity to any of the additives in the crizotinib drug formulation (silica, colloidal anhydrous cellulose, microcrystalline calcium hydrogen phosphate, anhydrous sodium starch glycolate, magnesium stearate).
    •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.
    • Qualsiasi disturbo GI che potrebbe influire sull'assorbimento di farmaci orali, quali sindrome da malassorbimento o stato successivo a resezione intestinale maggiore.
    • Somministrazione di forti/potenti inibitori o induttori del citocromo P4503A nei 14 giorni precedenti alla prima dose di trattamento dello studio e durante il trattamento con alectinib o crizotinib, fatta eccezione per i corticosteroidi orali fino a 20 mg di prednisolone o equivalente al giorno.
    • Somministrazione di farmaci con effetti potenziali di prolungamento dell'intervallo QT nei 14 giorni precedenti alla prima somministrazione di farmaco dello studio e durante il trattamento.
    • Anamnesi di ipersensibilità a uno qualsiasi degli eccipienti nella formulazione del farmaco alectinib (lattosio monoidrato, cellulosa microcristallina, sodio amido glicolato, idrossipropilcellulosa, sodio laurilsolfato [SLS], magnesio stearato).
    • Anamnesi di ipersensibilità a uno qualsiasi degli eccipienti nella formulazione del farmaco crizotinib (silice colloidale anidra, cellulosa microcristallina, calcio idrogenofosfato anidro, sodio amido glicolato, magnesio stearato).
    • Qualsiasi malattia o condizione concomitante clinicamente significativa che potrebbe interferire, o il cui trattamento potrebbe interferire, con la conduzione dello studio o con l'assorbimento di farmaci orali oppure che, secondo il parere dello sperimentatore principale, rappresenterebbe un rischio inaccettabile per il paziente in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from date of randomization to the date of first documented disease progression (as per RECIST 1.1) or death, whichever occurs first
    tempo trascorso dalla randomizzazione alla prima manifestazione documentata di progressione della malattia in base ai criteri RECIST v1.1, oppure al decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo.
    E.5.2Secondary end point(s)
    • PFS, which is defined as the time from randomization to the first documented disease progression, as determined by the investigators (primary endpoint) or IRC (secondary endpoint) using RECIST v1.1 or death from any cause, whichever occurs first. Patients without an event will be censored at the last tumor assessment either during follow-up or during study treatment. Patients with no post-baseline assessments will be censored at the date of randomization.
    • ORR, which is defined as the percentage of patients who attain CR or PR; response, as determined by the investigators using RECIST v1.1. Patients without any assessments will be regarded as non-responders.
    PFS, definita come il tempo trascorso dalla randomizzazione alla prima manifestazione documentata di progressione della malattia, determinata dagli sperimentatori (endpoint primario) o dall'IRC (endpoint secondario) in base ai criteri RECIST v1.1, oppure al decesso per qualsiasi causa, a seconda di quale evento si verifichi per primo. I pazienti senza un evento saranno censorizzati all'ultima valutazione del tumore durante il follow up o durante il trattamento dello studio. I pazienti senza valutazioni post-basali saranno censorizzati alla data della randomizzazione.
    ORR, definita come la percentuale di pazienti che conseguono una risposta completa (CR) o una risposta parziale (PR); la risposta è determinata dagli sperimentatori utilizzando i criteri RECIST v1.1. I pazienti senza alcuna valutazione saranno considerati come non responsivi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    New Zealand
    Philippines
    Poland
    Portugal
    Romania
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    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
    This study is event-driven, with a recruitment period of approximately 25 months.
    Questo studio è dipendente dagli eventi ed ha un periodo di arruolamento di circa 25 mesi. Si prevede che il numero richiesto di eventi per l'analisi finale dell'endpoint primario sarà raggiunto circa 31 mesi dopo l'arruolamento del primo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 286
    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)
    The Sponsor does not intend to provide alectinib or other study interventions to patients after conclusion of the study or any earlier patient withdrawal, under this protocol.
    Lo sponsor, nell’ambito di questo protocollo, non intende fornire alectinib nè altre prestazioni previste dallo studio ai pazienti che concludano la sperimentazione, né ai pazienti che dovessero uscire dallo studio prima della conclusione.
    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 Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-13
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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
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