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    Summary
    EudraCT Number:2014-001189-87
    Sponsor's Protocol Code Number:SAKK96/12
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-03
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-001189-87
    A.3Full title of the trial
    Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks - A Non-Inferiority Phase III trial
    Verhinderung von symptomatischen Komplikationen am Skelett mit Denosumab verabreicht alle 4 Wochen gegenüber alle 12 Wochen: Eine randomisierte Phase III Studie zum Nachweis einer vergleichbaren Wirksamkeit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of Denosumab when administered only every 12 weeks instead of every 4 weeks related to the prevention of complications on the bone skeleton
    Vergleich der Wirksamkeit von Denosumab, wenn es alle zwölf Wochen statt alle vier Wochen verabreicht wird in Bezug auf die Verhinderung von Komplikationen am Knochenskelett
    A.4.1Sponsor's protocol code numberSAKK96/12
    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 SponsorSwiss Group for Clinical Cancer Research
    B.1.3.4CountrySwitzerland
    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 supportSwiss Group for Clinical Cancer Research
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROLLL GmbH
    B.5.2Functional name of contact pointScientific Head
    B.5.3 Address:
    B.5.3.1Street AddressWörnitzstr. 115a
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90449
    B.5.3.4CountryGermany
    B.5.4Telephone number004991125268846
    B.5.6E-mailtobias.leidig@crolll.de
    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
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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
    Bone metastases from castration resistant prostate cancer or from breast cancer
    Knochenmetastasen von kastrationsresistentem Prostatakrebs oder Brustkrebs
    E.1.1.1Medical condition in easily understood language
    Breast cancer or prostate cancer with complications on the bone skeleton
    Brust- oder Prostatakrebs mit Komplikationen am Knochenskelett
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate 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
    The main objective is to establish that denosumab 120 mg given every twelve weeks is non-inferior to denosumab 120 mg given every four weeks.
    Die Hypothese dieser Studie ist, dass 120 mg Denosumab verabreicht alle zwölf Wochen vergleichbar wirksam ist (non inferior) mit 120 mg Denosumab verabreicht alle vier Wochen.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent
    2. ECOG Performance 0-2
    3. Age ≥ 18 years
    4. Confirmed diagnosis of breast or prostate cancer before randomization.
    5. Patient has metastatic breast cancer (stage IV, all subtypes allowed except small cells) or prostate cancer (stage IV, exception: small cells) and bone metastases and is planned to receive or is receiving antineoplastic treatment.
    6. Patients with prostate cancer must have evidence of disease Progression on continuous androgen deprivation therapy (CRPC).
    7. Patients must have ≥ three bone metastases (lytic or blastic or mixed).
    8. Corrected serum calcium ≥ 2 mmol/l and ≤ 3 mmol/l (medical treatments to obtain serum calcium levels in the normal range are allowed, as far as no denosumab is used. Maximally one dose of bisphosphonates in the case of hypercalcemia is allowed, if the bisphosphonate was applied at least three weeks before the first dose of denosumab).
    9. Liver transaminases not more than 1.5 x ULN or not more that 3 x ULN with liver metastases. Serum total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in case of known Gilbert's disease).
    E.4Principal exclusion criteria
    1. Definite contraindication for denosumab (e.g. hypocalcemia [Albumin-corrected serum calcium < 2.0 mmol/l]).
    2. History or current evidence of osteonecrosis of the jaw (ONJ).
    3. Non-healed mucosa in oral cavity (by surgery or as a side effect of any other Treatment).
    4. Jaw or dental conditions that require oral surgery or if surgery or invasive dental procedures are planned.
    5. Prior use of denosumab for bone metastases or bisphosphonates to treat bone metastases. Patients treated with denosumab or bisphosphonates against osteopenia or osteoporosis are followed to enter the trial if the last dose was more than 28 days before randomization.
    6. Patients with known osteoporosis (T-score ≤ -2.5) at study entry.
    7. Radiotherapy or surgery to the bone within the last two weeks before randomization or planned within six weeks after randomization.
    8. Presence or history of CNS metastases or leptomeningeal disease. A MRI Evaluation within twelve weeks before randomization must be performed in case of suspicious symptoms.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first on-trial symptomatic skeletal event (SSE; clinically significant pathological fracture, radiotherapy to bone or spinal cord compression).
    Zeit bis zum ersten Auftreten eines symptomatischen skelletalen Ereignisses innerhalb der Studie (klinisch signifikante pathologische Fraktur, Radiotherapie des Knochens, chirurgischer Eingriff am Knochen oder Rückenmarkskompression).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 1 (Baseline) and than every twelve weeks over five years
    Woche 1 (Baseline) anschließend alle zwölf Wochen über fünf Jahre
    E.5.2Secondary end point(s)
    1. Toxicity (Focus on hypocalcemia and osteonecrosis of the jaw)
    2. Time to first and subsequent on-trial SSE
    3. Overall survival (OS)
    4. Quality of life (QoL)
    5. Skeletal morbidity period rate (SMPR)
    6. Skeletal morbidity rate (SMR)
    1. Toxizität
    2. Zeit bis zum ersten und nachfolgenden SSE innerhalb der Studie
    3. Gesamtüberleben
    4. Lebensqualität
    5. “Skeletal morbidity period rate” (SMPR; Skelett Morbiditäts-Perioden Rate)
    6. “Skeletal morbidity rate” (SMR; Skelett Morbiditätsrate)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 1 (Baseline) and than every twelve weeks over five years
    Woche 1 (Baseline) anschließend alle zwölf Wochen über fünf Jahre
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Denosumab appliziert alle zwölf Wochen
    Denosumab administered every twelve weeks
    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 concerned3
    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 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
    Germany
    Switzerland
    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
    LPLV - last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years10
    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: 460
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 920
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 1380
    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)
    Denosumab is an approved treatment in the European Union, and continuing treatment with Denosumab after end of trial via prescription will be left to the descretion of the subject and investigator.
    Denosumab in eine zugelassene Behandlung in der Europäischen Union. Die Behandlung mit Denosumab als verschreibungspflichtiges Medikament kann nach Studienabschluss weitergeführt werden. Die Entscheidung liegt im Ermessen des Prüfarztes bzw. erfolgt nach Wunsch des Patienten.
    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 Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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