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    Summary
    EudraCT Number:2019-000593-32
    Sponsor's Protocol Code Number:MIT-Zo002-C301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-28
    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 - BfArM
    A.2EudraCT number2019-000593-32
    A.3Full title of the trial
    Phase III, open-label, multi-center study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 10.8 mg goserelin subcutaneous implant (Novalon) in male subjects with prostate cancer.
    Unverblindete, multizentrische Phase-III-Studie zur Beurteilung der Pharmakodynamik (PD), Pharmakokinetik (PK) und Sicherheit des subkutanen Goserelin-Implantats Zoreline 10,8 mg (Novalon) bei männlichen Patienten mit Prostatakrebs.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An experimental study in men with prostate cancer to investigate the drug Zoreline 10.8 mg on its effects on the human body and safety.
    A.4.1Sponsor's protocol code numberMIT-Zo002-C301
    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 SponsorNovalon S.A.
    B.1.3.4CountryBelgium
    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 supportNovalon S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointMonique Muller
    B.5.3 Address:
    B.5.3.1Street AddressWalaardt Sacréstraat 401-403
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 BM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31204350 580
    B.5.6E-mailregulatory@sms-oncology.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 nameZoreline
    D.3.4Pharmaceutical form Implant in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGoserelin
    D.3.9.3Other descriptive nameGOSERELIN ACETATE
    D.3.9.4EV Substance CodeSUB02400MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.8
    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
    Prostate cancer
    Prostatakrebs
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    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
    To assess the ability of Zoreline 10.8 mg subcutaneous implant to induce testosterone serum suppression (≤50 ng/dL) in male subjects with prostate cancer by Day 29 of Cycle 1 at the latest and have this confirmed at Day 85 of Cycle 1 and Day 85 of Cycle 2 (End of Treatment)
    Um die Fähigkeit von Zoreline 10,8 mg als subkutanes Implantat, zur Herbeiführung der Testosteron-Serumunterdrückung (≤50 ng/dL) bei männlichen Patienten mit Prostatakrebs spätestens am 29. Tag des Zyklus 1 zu beurteilen und dies am 85. Tag des Zyklus 1 und am 85. Tag des Zyklus 2 (Ende der Behandlung) bestätigt.
    E.2.2Secondary objectives of the trial
    • To assess general safety and acceptability of the drug and syringe combination in line with standard of care
    • To characterize the goserelin plasma concentration profile (time to reach Cmax [Tmax], minimum plasma concentration [Cmin], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]) from Day 1 to Day 85 in each treatment cycle, i.e. during two consecutive treatment cycles in which Day 85 represents the end of treatment of each cycle. The area under the curve will be extrapolated to infinity (AUC0-∞) and terminal (apparent elimination) half-life (t½) will be determined
    • To characterize the testosterone serum concentration profile (Cmax, AUC) including initial surge between Day 1 and Day 29 of Cycle 1, time to achieve castration level, acute on chronic phenomenon, surge at re-injection and potential escape (surge) following the onset of suppression after the initial surge
    •Beurteilung der allgemeinen Sicherheit und Akzeptanz der Kombination von Medikament und Injektionsspritze im Einklang mit dem Pflegestandard.
    •Charakterisierung des Goserelin-Plasmakonzentrationsprofils (Zeit bis zum Erreichen von Cmax [Tmax], minimale Plasmakonzentration [Cmin], maximale Plasmakonzentration [Cmax], Bereich unter der Plasmakonzentrationszeitkurve [AUC]) von Tag 1 bis Tag 85 in jedem Behandlungszyklus, d. h. während zwei aufeinanderfolgenden Behandlungszyklen, in denen Tag 85 das Ende der Behandlung jedes Zyklus darstellt. Der Bereich unter der Kurve wird auf unendlich hochgerechnet (AUC0-∞) und die terminale Halbwertzeit (t½) wird bestimmt.
    •Bestimmung des Testosteron-Serum-Konzentrationsprofils (Cmax, AUC) anfänglicher Anstieg zwischen Tag 1 und Tag 29 von Zyklus 1, Zeit bis zum Erreichen des Kastrationsniveaus, akut bei chronischem Phänomen, Anstieg bei erneuter Injektion und möglichem Ausbruch (Anstieg) nach dem Beginn der Unterdrückung nach dem ersten Anstieg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males aged 18 years (inclusive) or above
    2. Histologically confirmed prostate adenocarcinoma and indicated for ADT. This includes but is not limited to subjects suffering from Localized intermediate-risk or high-risk Prostate Cancer (having a clinical state of T2b and ≥T2c) and subjects with Locally Advanced Prostate Cancer (having T3-4 as clinical state) [Mottet, 2018; NICE Guideline, 2014]. Previous prostatectomy and/or prostate radiotherapy is allowed.
    3. Willing to give informed consent in writing
    4. Willing and able to attend the scheduled study visits and to comply with the study procedures
    5. Testosterone level > 250 ng/dL
    6. PSA level ≥ 4 ng/mL
    Exception: for subjects who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
    7. Life expectancy > 1 year
    8. Body Mass Index between 18.5 and 35.0 kg/m2 inclusive
    9. ECOG score of ≤2
    1. Männlich, 18 Jahre ( einschließlich) oder älter.
    2. Histologisch bestätigtes Prostata-Adenokarzinom und indiziert für ADT. Dies beinhaltet, ist aber nicht beschränkt auf Personen, die an lokalisiertem Prostatakrebs mit mittlerem oder hohem Risiko leiden (mit einem klinischen Zustand von T2b und ≥T2c) und Personen mit lokal fortgeschrittenem Prostatakrebs (mit T3-4 als klinischem Zustand) [Mottet, 2018; NICE Guideline, 2014]. Eine frühere Prostatektomie und/oder Prostata-Strahlentherapie ist erlaubt.
    3. Bereitschaft zur schriftlichen Einwilligung nach Aufklärung
    4. Bereitschaft und Fähigkeit zur Teilnahme an den geplanten Studienbesuchen und zur Einhaltung der Studienverfahren
    5. Gesamttestosteronspiegel > 250 ng/dL
    6. PSA-Wert ≥ 4 ng/mL
    Ausnahme: bei Probanden, die bereits eine Prostatektomie und/oder Prostata-Strahlentherapie durchgeführt haben, sind alle PSA-Werte erlaubt.
    7. Lebenserwartung > 1 Jahr
    8. Body Mass Index zwischen 18,5 und 35,0 kg/m2 einschließlich
    9. ECOG-Wertung von ≤2
    E.4Principal exclusion criteria
    1. Hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including gonadotrophin-releasing hormone (GnRH) receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit (with a maximum of 2 previous treatment cycles allowed in case of GnRH analog treatment)
    2. Scheduled for prostatectomy or prostate radiotherapy during study period
    3. Any subject at risk as per Investigator’s judgement for urinary obstruction or spinal cord compression due to potential testosterone surge
    4. Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≥2x upper limit of normal (ULN)
    5. Estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <50 mL/min/1.73m2 at screening visit
    6. Has received an investigational drug within the last 28 days before Visit 2 (Cycle 1 Day 1) or longer if considered by the Investigator to possibly influencing the outcome of this study
    7. History or presence of any malignancy other than adequately treated squamous cell /basal cell carcinoma of the skin within the last five years
    8. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion. A profound risk-benefit assessment should be done when the subject is suffering from diabetes mellitus, osteoporosis or cardiovascular disease because of possible adverse events
    9. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study medication
    10. Hypersensitivity to GnRH and its analogues
    11. Other abnormal laboratory results which in the judgment of the Investigator would affect the subject's health or the outcome of the study
    12. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
    1. Hormonelle Behandlung von Prostatakrebs (chirurgische Kastration oder andere hormonelle Eingriffe, einschließlich Gonadotropin-Releasing-Hormon-(GnRH)-Rezeptor-Agonisten, GnRH-Rezeptor-Antagonisten, Anti-Androgenen, Östrogenen, 5 Alpha-Reduktase-Inhibitoren) innerhalb von 6 Monaten vor dem Screening-Besuch (mit maximal 2 vorherigen Behandlungszyklen im Falle einer GnRH-Analogbehandlung)
    2. Eingeplant für Prostatektomie, Chemotherapie oder Prostata-Strahlentherapie während der Studiendauer.
    3. Jede gefährdete Testperson, die nach dem Ermessen des Prüfarztes für eine Harnwegsobstruktion oder eine Rückenmarkkompression aufgrund eines möglichen Testosteronschubs gefährdet ist.
    4. Alanin-Aminotransferase (ALT) oder Aspartat-Transaminase (AST) ≥2x des oberen Normwertes (ULN).
    5. Geschätzte glomeruläre Filtrationsrate (eGFR), unter Verwendung der Modifikation der Ernährung bei Nierenerkrankungen (MDRD) Gleichung, <50 ml/min/1,73 m2 beim Screening-Besuch.
    6. Hat ein Prüfpräparat innerhalb der letzten 28 Tage vor Besuch 2 (Zyklus 1 Tag 1) oder länger erhalten, wenn der Prüfarzt es für möglich hält, das Ergebnis dieser Studie zu beeinflussen.
    7. Vorgeschichte oder Vorhandensein von Malignomen, die keine adäquat behandelten Plattenepithelkarzinome/Basaliome der Haut sind, innerhalb der letzten fünf Jahre.
    8. Eine instabile Erkrankung oder chronische Erkrankung (einschließlich der Vorgeschichte von neurologischen (einschließlich kognitiven), hepatischen, renalen, gastrointestinalen, pulmonalen oder endokrinen Erkrankungen) oder Malignität haben, welche die Interpretation der Studie nach Ermessen des Prüfers verfälschen könnte. Eine gründliche Risiko-Nutzen-Bewertung sollte durchgeführt werden, wenn die Versuchsperson an Diabetes mellitus, Osteoporose oder Herz-Kreislauf-Erkrankungen aufgrund möglicher Nebenwirkungen leidet.
    9. Vorgeschichte von schwerem unkontrolliertem Asthma, anaphylaktischen Reaktionen oder schwerem Urtikaria- und/oder Angioödem, und insbesondere Vorgeschichte von Überempfindlichkeit gegenüber allen Komponenten des Prüfmedikaments.
    10. Überempfindlichkeit gegen GnRH und seine Analoga
    11. Andere anormale Laborergebnisse, die nach Ansicht des Prüfarztes die Gesundheit des Patienten oder das Ergebnis der Studie beeinträchtigen würden.
    12. Besitzt eine intellektuelle Unfähigkeit oder Sprachbarriere, die ein angemessenes Verständnis oder eine angemessene Zusammenarbeit verhindert.
    E.5 End points
    E.5.1Primary end point(s)
    The ability of Zoreline 10.8 mg subcutaneous implant to induce testosterone serum suppression (≤50 ng/dL) in male subjects with prostate cancer by Day 29 of Cycle 1 at the latest and have this confirmed at Day 85 of Cycle 1 and Day 85 of Cycle 2 (End of Treatment)
    Die Fähigkeit von Zoreline 10,8 mg als subkutanes Implantat, zur Herbeiführung der Testosteron-Serumunterdrückung (≤50 ng/dL) bei männlichen Patienten mit Prostatakrebs spätestens am 29. Tag des Zyklus 1 zu beurteilen und hat dies am 85. Tag des Zyklus 1 und am 85. Tag des Zyklus 2 (Ende der Behandlung) bestätigt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29 of Cycle 1, Day 85 of Cycle 1 and Day 85 of Cycle 2
    E.5.2Secondary end point(s)
    Pharmacodynamics:
    • Serum concentrations of testosterone including initial surge between Day 1 and Day 29 of Cycle 1, time to achieve castrate level, acute on chronic phenomenon, surge(s) at re-injection and potential escape (surge) following the onset of suppression after the initial surge in Cycle 1 to Day 85 of Cycle 1 (pre-dose of Cycle 2) and after the surge at re-injection in Cycle 2 to Day 85 of Cycle 2 (End of Treatment)
    Pharmacokinetics:
    • Plasma concentrations of goserelin
    Safety:
    • Occurrence of serious and non-serious adverse events, including local assessment of the injection site
    Pharmakodynamik:
    • Serumkonzentrationen von Testosteron einschließlich anfänglichem Anstieg zwischen Tag 1 und Tag 29 des Zyklus 1, Zeit zum Erreichen des Kastratspiegels, akut bei chronischen Phänomenen, Anstieg(e) bei der Reinjektion und potenziellem Ausbrechen (Anstieg) nach dem Beginn der Unterdrückung nach dem anfänglichen Anstieg in Zyklus 1 bis Tag 85 des Zyklus 1 (Vordosierung von Zyklus 2) und nach dem Anstieg bei der Reinjektion in Zyklus 2 bis Tag 85 des Zyklus 2 (Ende der Behandlung).
    Pharmakokinetik
    • Plasmakonzentrationen von Goserelin
    Sicherheit
    • Auftreten schwerwiegender und nicht schwerwiegender unerwünschte Ereignisse, einschließlich der lokalen Beurteilung der Injektionsstelle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints mentioned in bullet E.5.2 (secondary endpoint)
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned14
    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
    Georgia
    Moldova, Republic of
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 142
    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 (routine care)
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-06
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