Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-000799-14
    Sponsor's Protocol Code Number:0080CA002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000799-14
    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 patients with prostate cancer
    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.3.2Name or abbreviated title of the trial where available
    0080CA002
    A.4.1Sponsor's protocol code number0080CA002
    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 pointEveline Verheijen
    B.5.3 Address:
    B.5.3.1Street AddressScience Park 408
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1098 XH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310204350580
    B.5.5Fax number+310204350589
    B.5.6E-mailofficemanager@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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGoserelin
    D.3.9.1CAS number 145781-92-6
    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
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term 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 primary objective of the study is to assess the ability of Zoreline 10.8 mg SC implant to induce by Day 29 of Cycle 1 at the latest and maintain up to Day 85 of Cycle 2 (end of treatment) testosterone plasma suppression (≤50 ng/dL) in male patients with prostate cancer.
    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 (Tmax, Cmin, Cmax, 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 if possible.
    •To characterize the testosterone plasma concentration profile (Cmax, AUC) including initial flare between Day 1 and Day 29 of Cycle 1, time to achieve castration level, acute on chronic phenomenon (surge at re-injection between Day 2 and Day 4 of Cycle 2) and potential escape (surge) following the onset of suppression after the initial flare in Cycle 1 to Day 85 of Cycle 1 (pre-dose Day 1 of Cycle 2) and from Day 8 until Day 85 of Cycle 2 (end of treatment).
    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 androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy is allowed.
    3. Good physical and mental health as judged by the Investigator determined by medical history, physical examination, clinical laboratory and vital signs
    4. Willing to give informed consent in writing
    5. Willing and able to attend the scheduled study visits and to comply with the study procedures
    6. Baseline testosterone level > 250 ng/dL
    7. PSA level ≥ 4 ng/mL
    Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
    8. Life expectancy > 1 year
    9. Body Mass Index between 18.5 and 35 kg/m2 inclusive
    10. ECOG score of ≤2
    E.4Principal exclusion criteria
    1. Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens) within 6 months prior to the Screening visit
    2. Scheduled for prostatectomy or radiotherapy during study period
    3. ALT (SGOT) or AST (SGPT) ≥2x upper limit of normal (ULN)
    4. moderate (stage 3B) or severe (stage 4 and 5) chronic kidney disease with an eGFR <45 mL/min/1,73m2
    5. Has received an investigational drug within the last 28 days before the screening visit or longer if considered by the Investigator to possibly influencing the outcome of this trial
    6. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last five years
    7. Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion
    8. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study drug
    9. Other abnormal laboratory results which in the judgment of the Investigator would affect the patient's health or the outcome of the trial
    10. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamics:
    The primary objective will be considered as achieved if the lower limit of the 2-sided 95% confidence interval (CI) on the responder rate is ≥90%. A responder is defined as a subject who reached plasma testosterone levels below the castrate level (≤50 ng/dL) by Day 29 of Cycle 1 at the latest and maintained plasma testosterone levels below the castrate level (≤50 ng/dL) until Day 85 of Cycle 2 (end of treatment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 1 Day 29 and Cycle 2 Day 85
    E.5.2Secondary end point(s)
    Pharmacodynamics:
    • Plasma concentrations of testosterone including initial flare between Day 1 and Day 29 of Cycle 1, time to achieve castrate level, acute on chronic phenomenon (surge(s) at re-injection) between Day 2 and Day 4 of Cycle 2 and potential escape (surge) following the onset of suppression after the initial flare in Cycle 1 to Day 85 of Cycle 1 (pre-dose of Cycle 2) and from Day 8 until day 85 of Cycle 2 (end of treatment).

    Pharmacokinetics:
    • Plasma concentrations of goserelin

    Safety:
    • Occurrence of serious and non-serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken during screening, on day 1, 2, 4, 8, 15, 29, 36 and 57 of cycle 1 and on day 1, 2, 4, 8, 15, 29, 36, 57 and 85 of cycle 2.

    Safety:
    Adverse events will continuously be monitored from signing of informed consent untill the last study related activity.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    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 Decision2015-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 15:53:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA