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    Summary
    EudraCT Number:2017-001758-32
    Sponsor's Protocol Code Number:20140114
    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:2018-10-19
    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 number2017-001758-32
    A.3Full title of the trial
    Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
    Follow-up sulla sicurezza a lungo termine dei pazienti con tumore a cellule giganti dell’osso trattati con denosumab nello studio 20062004
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety Follow-up of Subjects With Giant Cell Tumour of Bone Treated With Denosumab in Study 20062004
    Follow-up sulla sicurezza a lungo termine dei pazienti con tumore a cellule giganti dell’osso trattati con denosumab nello studio 20062004
    A.3.2Name or abbreviated title of the trial where available
    A
    NA
    A.4.1Sponsor's protocol code number20140114
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info – Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041413690100
    B.5.5Fax number0041413690300
    B.5.6E-mailMedinfoInternational@amgen.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 XGEVA - 120 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 1.7 ML 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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 nameDenosumab
    D.3.2Product code AMG 162
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    Giant Cell Tumour of Bone
    Tumore a cellule giganti dell’osso
    E.1.1.1Medical condition in easily understood language
    Giant Cell Tumour of Bone
    Tumore a cellule giganti dell’osso
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10005968
    E.1.2Term Bone giant cell tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate adverse events of interest in subjects with GCTB treated with
    denosumab in Study 20062004
    Valutare eventi avversi d’interesse nei soggetti con GCTB trattati con denosumab nello studio 20062004
    E.2.2Secondary objectives of the trial
    Evaluate treatment-emergent adverse events for subjects who are
    receiving
    denosumab
    Evaluate serious adverse events for all subjects
    Summarize the rate of disease progression or recurrence of GCTB for all
    subjects
    Summarize the use of GCTB interventions for all subjects
    Tasso di eventi avversi emersi durante il trattamento per i soggetti che stanno ricevendo denosumab
    Tasso di eventi avversi gravi per tutti i soggetti
    Tasso di progressione o recidiva del GCTB per tutti i soggetti
    Tasso di interventi per il GCTB per tutti i soggetti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is currently enrolled in Study 20062004.
    - Subject or subject's legally acceptable representative has provided
    informed
    consent/assent prior to initiation of any study-specific
    activities/procedures.
    Tutti i soggetti dello studio 20062004 che danno il proprio consenso a partecipare a questo studio e che firmano l’ICF saranno considerati arruolati.
    E.4Principal exclusion criteria
    - Subject likely to not be available to complete all protocol-required
    study visits or procedures, and/or to comply with all required study
    procedures to the best of the subject and investigator's knowledge.
    - Females of childbearing potential on denosumab and not willing to
    continue to use 1 highly effective method of contraception during
    treatment and for 5 months after the end of treatment.
    - Sggetto che potrebbe non essere disponibile per completare tutte le visite o procedure di studio richieste dal protocollo
    e / o rispettare tutte le procedure necessarie
    nelle migliori conoscenze del soggetto e del ricercatore.
    - Donne potenzialmente riproduttive e non disposte
    a continuare ad usare 1 metodo di contraccettazione altamente efficace durante il trattamento e per 5 mesi dopo la fine del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of adverse events of interest in subjects with GCTB treated with
    denosumab in Study 20062004
    Tasso di eventi avversi d’interesse nei soggetti con GCTB trattati con denosumab nello studio 20062004
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout whole duration of study
    Durante tutta la durata dello studio
    E.5.2Secondary end point(s)
    Rate of treatment-emergent adverse events for subjects who are
    receiving
    denosumab
    Rate of serious adverse events for all subjects
    Rate of disease progression or recurrence of GCTB for all subjects
    Rate of GCTB interventions for all subjects
    Tasso di eventi avversi emersi durante il trattamento per i soggetti che stanno ricevendo denosumab
    Tasso di eventi avversi gravi per tutti i soggetti
    Tasso di progressione o recidiva del GCTB per tutti i soggetti
    Tasso di interventi per il GCTB per tutti i soggetti
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout whole duration of study
    Durante tutta la 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 No
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Follow up
    Follow up
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Germany
    Italy
    Poland
    Spain
    Sweden
    United Kingdom
    United States
    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 EOS date is defined as the date when the last subject across all
    sites is assessed or receives an intervention for evaluation in the study
    (ie, last subject
    last visit), following any additional parts in the study (eg, long-term
    follow-up), as applicable.
    La data di EOS è definita come la data in cui l'ultimo soggetto in tiutti i centri è valutato o riceve un intervento per la valutazionr ai fini dello studio (es: LPLV) in seguito a ogni parte ulteriore dello studio (es: long Tem follow-up)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 350
    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
    Nessuno
    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 Decision2017-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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