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    Summary
    EudraCT Number:2004-000512-17
    Sponsor's Protocol Code Number:20040138
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-07-16
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-000512-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in the
    Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for
    Non-metastatic Prostate Cancer
    A.4.1Sponsor's protocol code number20040138
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameDenosumab
    D.3.2Product code AMG 162
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 615258
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameAbx 1-6 CHO OPG Ligand mAb IgG2; Human Monoclonal Antibody to RANKL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bone loss in pateints undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10049470
    E.1.2Term Bone density decreased
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the treatment effect of AMG 162 compared with placebo on lumbar
    spine bone mineral density (BMD) at month 24 in men with nonmetastatic prostate cancer undergoing ADT.
    E.2.2Secondary objectives of the trial
    - To assess the effect of AMG 162 compared with placebo on the following:
    – Percent change of femoral neck BMD, and total hip BMD from baseline to month 24
    – Percent change of lumbar spine BMD, femoral neck BMD and total hip BMD from baseline to month 36
    – Subject incidence of any fracture and subject incidence of new vertebral fracture over the 36-month evaluation period
    – Time to first clinical fracture over the 36-month evaluation period
    – Subject incidence of any fracture over the 24- month evaluation period

    - To assess the safety and pharmacokinetics of AMG 162 in this population. Safety will be followed for up to 2 years after the end of the 36-month treatment phase (as described in Section 7.18).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dual X-ray Absorptiometry sub-study (please see section 7.16 of protocol 20040138 for further details)
    E.3Principal inclusion criteria
    - Patients ≥ 70 years of age, with histologically confirmed prostate cancer
    or
    - Adult patients, < 70 years of age, with histologically confirmed prostate cancer and a history of osteoporotic fracture, or BMD t-score at the lumbar spine, total hip, or femoral neck < -1.0 (BMD using the male normative database)
    - Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and
    is expected to continue on with ADT for at least 12 months
    - ECOG score 0, 1, or 2
    - Before any study-specific procedure, provide written informed consent
    E.4Principal exclusion criteria
    - Evidence of distant metastases
    - Concurrent systemic anti-neoplastic therapy, other than ADT and/or antiandrogen
    therapy
    - Diagnosis of any secondary non- prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin
    - PSA > 5 ng/mL after being on ADT >1 month
    - BMD t-score < -4.0 at lumbar spine, total hip, or femoral neck
    - Height, weight, and girth which may preclude accurate DXA measurements
    - Less than 2 evaluable lumbar vertebrae (L1-L4) for DXA measurement
    - Current administration of oral bisphosphonates, or previous use as follows:
    • Greater than or equal to 3 years continuously
    • Greater than 3 months but less than 3 years (eligible only if patient has a 1 year washout prior to randomization)
    - Current administration of IV bisphosphonates, fluoride, strontium ranelate, or gallium nitrate, within the past 5 years
    - Administration of any of the following treatments within the past 6 weeks:
    • PTH or PTH derivatives
    • Anabolic steroids or testosterone
    • Glucocorticoids (> 10 mg prednisone/day for more than 10 days)
    • Selective estrogen receptor modulators (SERMS)
    • Calcitonin
    • Calcitriol
    - Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy (topical, inhaled, or nasal steroids are allowed)
    - Prior administration of OPG construct (i.e. AMGN-0007, Fc-OPG), or AMG 162
    - Concurrent use of PC SPES
    - 25-hydroxyvitamin D deficiency (< 12 ng/mL)
    - Serum calcium or albumin-adjusted serum calcium levels < 2.0 mmol/L (8.0 mg/dL), or ≥2.9 mmol/L (11.5 mg/dL)
    - Serum creatinine > 177 µmol/L (>2.0 mg/dL)
    - Hepatic insufficiency [AST > 2.5 x upper limit of normal (ULN), ALT > 2.5 x ULN, or total bilirubin > 1.5 x ULN]
    - iPTH > 1.5 x ULN
    - ANC < 1.5 x 109/L; platelets < 100 x 109/L; or hemoglobin < 6.2 mmol/L (10.0
    g/dL)
    - Evidence of any of the following conditions per subject self report or chart review:
    a) Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range)
    b) Paget’s disease, Cushing’s disease, hyperprolactinemia, or chronic liver disease
    c) Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization
    d) Major surgery, or significant traumatic injury occurring within 4 weeks before randomization
    e) Known HIV, HCV, or chronic Hepatitis B infection
    - Organic or psychiatric disorder which, in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results
    - Any kind of disorder that compromises his ability to give written informed consent and/or to comply with study procedures
    - Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device. Subjects in the observational phase of clinical studies ( eg, to collect survival data) are allowed
    - Self-reported drug or alcohol abuse within the previous 24 weeks before study enrollment
    - Known sensitivity to any of the products to be administered during this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 EEA37
    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
    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
    Last visit of last subject
    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 months9
    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 months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 323
    F.4.2.2In the whole clinical trial 1468
    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)
    Expected normal treatment
    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 Decision2004-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-14
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