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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-001606-16
    Sponsor's Protocol Code Number:20062004
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-24
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-001606-16
    A.3Full title of the trial
    An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety Study of Denosumab in Subjects With Recurrent or Unresectable Giant Cell Tumor of Bone
    A.4.1Sponsor's protocol code number20062004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00680992
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/14/2010
    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 code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberNANANANA
    B.5.5Fax numberNANANANA
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameImmunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) 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 tumor of bone (GCTB)
    E.1.1.1Medical condition in easily understood language
    Giant cell tumor of bone
    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 100000019081
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety profile of denosumab in subjects with GCTB
    E.2.2Secondary objectives of the trial
    - Evaluation of time to disease progression in subjects with unsalvageable GCTB treated with denosumab (cohort 1)
    - Evaluation of the proportion of subjects who do not require surgery in denosumab treated subjects with salvageable GCTB (cohort 2)
    - to evaluate denosumab pharmacokinetics (PK) in adolescent and adult subjects with GCTB (PK subset)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic substudy introduced as part of Protocol Amendment 7 dated 15 May 2013:
    Serum samples (for serum denosumab concentration levels and sCTx) and urine samples (for urinary N-telopeptide [uNTx]; urine analytes will include creatinine and raw N-telopeptide [NTx]) will be obtained on a subset of approximately 20 subjects (approximately
    10 adolescent and 10 adult subjects) at baseline (prior to administration of investigational product on study day 1) and on study as outlined in the schedule of assessments (Appendix A) of the protocol. Amgen Inc or
    its designee will be responsible for analyzing these samples and will measure urine creatinine.
    The primary purpose of this substudy is to provide sufficient PK data to empirically compare trough exposures between 10 adolescent and 10
    adult patients through steady-state (month 4).
    E.3Principal inclusion criteria
    - Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment
    - Measurable evidence of active disease within 1 year before study enrollment
    - Subjects with surgically unsalvageable disease (eg, sacral, spinal GCT, or multiple lesions including pulmonary metastases) OR subjects whose planned initial surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity, other than curettage with complete resection of tumor
    - Karnofsky performance status ≥ 50% (ie, ECOG status 0, 1, or 2)
    - Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerous with closed growth epiphyseal plate]) ≥ 12 years of age
    - Skeletally mature adolescents must weigh at least 45 kg
    - Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
    Inclusion Criteria for 20040215 subjects:
    - Subjects currently enrolled in study 20040215
    - Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
    E.4Principal exclusion criteria
    - Currently receiving other GCTB specific treatment (eg, radiation, chemotherapy, or embolization)
    - Concurrent bisphosphonate treatment
    - Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
    - Known or suspected current diagnosis of non GCTB giant cell-rich tumors
    - Known or suspected current diagnosis of brown cell tumor of bone or Paget’s disease
    - Known diagnosis of second malignancy within the past 5 years (subjects with definitively treated basal cell carcinoma and cervical
    carcinoma in situ are permitted)
    - Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
    - Active dental or jaw condition which requires oral surgery, including tooth extraction
    - Non-healed dental/oral surgery
    - Planned invasive dental procedure for the course of the study
    - Unstable systemic disease including active infection, uncontrolled
    hypertension, unstable angina, congestive heart failure, or myocardial
    infarction within 6 months before enrollment
    - Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s)
    - Subject has known sensitivity to any of the products to be administered during dosing
    - Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
    - Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
    - Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
    - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    Exclusion Criteria for 20040215 subjects:
    - Developed sensitivity to mammalian cell derived drug products during the 20040215 study
    - Currently receiving any unapproved investigational product other than
    denosumab
    - Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment
    - Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
    - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analyses and final analysis
    E.5.2Secondary end point(s)
    1- Time to disease progression for cohort 1
    2- Proportion of subjects without any surgery at month 6 for cohort 2
    3- Serum denosumab (trough) concentrations (PK subset)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Interim analyses and final analysis
    2- Month 6
    3- Month 6
    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 No
    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) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    European Union
    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 end of the clinical trial for all subjects will occur when subjects enrolled through November 2012 (before Amendment 7) have completed at least 60 months on study, or until death or lost to followup, whichever comes first. Study enrollment (prior to Amendment 7)concluded in November 2012; therefore the final study visits will be
    conducted and the study is anticipated to end by approximately November 2017.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    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: 28
    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: 28
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 479
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (12-17 years) skeletally mature and weighing at least 45 kgs (see inclusion criteria)
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 354
    F.4.2.2In the whole clinical trial 530
    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)
    Standard of care for the condition
    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 Decision2008-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-11
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