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    Summary
    EudraCT Number:2015-001756-30
    Sponsor's Protocol Code Number:No0002-C201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-001756-30
    A.3Full title of the trial
    Open-label, multi-center, randomized parallel group study to assess the pharmacokinetic (PK) profile of Zoreline 10.8 mg goserelin subcutaneous implant (test product, Novalon S.A.) and of Zoladex® LA 10.8 mg goserelin subcutaneous implant (reference product, AstraZeneca UK Limited) in male patients with prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in males with prostate cancer performed in several centers to assess the blood levels after injection of two subcutaneous implants containing 10.8 mg goserelin
    A.4.1Sponsor's protocol code numberNo0002-C201
    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 organisationNovalon S.A.
    B.5.2Functional name of contact pointCMC Project Leader
    B.5.3 Address:
    B.5.3.1Street AddressRue Saint Georges 5-7
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 (0)42669492
    B.5.5Fax number+32 (0)43492821
    B.5.6E-mailkvanbutsele@novalon.be
    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 10.8 mg implant
    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 65807-02-5
    D.3.9.4EV Substance CodeSUB07962MIG
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Zoladex® LA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 65807-02-5
    D.3.9.4EV Substance CodeSUB07962MIG
    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 18.1
    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
    To characterize the goserelin plasma concentration profile based on primary pharmacokinetic endpoints from Day 1 to 85 (1 treatment cycle, Day 85 represents the end of treatment), after injection with Zoreline 10.8 mg or Zoladex® LA 10.8 mg subcutaneous implant in male patients with prostate cancer
    E.2.2Secondary objectives of the trial
    - To characterize additional PK parameters (plasma concentration at the end of the treatment period [CDay85], time to reach Cmax [tmax]).
    - To characterize the testosterone plasma concentration (PD) profile including initial flare between Day 1 and Day 28 and time to achieve castrate level (≤50 ng/dl) after injection with Zoreline 10.8 mg or Zoladex® LA 10.8 mg subcutaneous implant
    - To assess general safety and acceptability of the drug in both groups

    Exploratory:
    • To assess the performance of a novel syringe used to inject Zoreline 10.8 mg subcutaneous implant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males Age 18 years (inclusive) or above
    2. Histologically confirmed prostate adenocarcinoma and indicated for androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy are 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. Testosterone level > 2.5 ng/mL at screening
    7. PSA level ≥4ng/mL.
    Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
    8. Life expectancy > 1 year assessed at screening or within the last month
    9. Body Mass Index between 18.5 and 35kg/m2 inclusive
    10. ECOG score of ≤2 measured at screening
    E.4Principal exclusion criteria
    1. Previous or current hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5 alpha reductase inhibitors) within 6 months prior to the screening visit. All other prohibited medications that are listed in Appendix 3 should not have been administered within the last 3 months prior the study drug administration
    2. Scheduled for prostatectomy or prostate radiotherapy during study period
    3. Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST) / serum glutamic oxaloacetic transaminase (SGOT) ≥2x upper limit of normal (ULN) or GGT ≥2.5 x upper limit of normal
    4. Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history for chronic hepatic disease
    Moderate or severe chronic kidney disease with an estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <60 mL/min/1,73m2
    6. Has received an investigational drug within the last 28 days before the Screening visit or 5 times the half-life of the drug whichever is longer if considered by the investigator to possibly influencing the outcome of this trial
    7. History or presence of any malignancy other than prostate cancer and 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], cardiovascular, gastrointestinal, pulmonary, or endocrine disease), that could confound interpretation of the study at investigator discretion
    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 drug
    10. Other abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
    11. Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
    12. Have a prolonged QTc interval defined as mean QTcB > 450 ms at Screening. If the mean value of QTcB interval from the three measurements is above 450 ms, another triplicate ECG could be recorded once on the same day
    13. Have a family history for prolonged QT interval including a history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or a personal history of syncope
    14. Evidence or history for significant active cardiac disease (e.g., congestive heart failure, mitral valve regurgitation, endocarditis, coronary artery heart disease), or symptoms of angina pectoris or transient ischaemic attacks
    E.5 End points
    E.5.1Primary end point(s)
    - Maximum measured goserelin plasma concentration in both groups (Cmax)
    - Area under the goserelin plasma concentration curve from administration to the last measurable concentration at time t in both groups (AUC0-t)
    - Area under the goserelin plasma concentration curve from administration to the last common measurable time-point within all patients in both groups (AUC0-tcom)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation of these endpoints are described in table 8.1-1 of the protocol.
    E.5.2Secondary end point(s)
    Pharmacokinetics (PK):
    - Time until the maximum goserelin plasma concentration is reached (t max)
    - Goserelin plasma concentration at the end of the treatment period (CDay85)

    Pharmacodynamics (PD):
    - Maximum measured testosterone plasma concentration in both groups (Cmax)
    - Area under the testosterone plasma concentration curve from administration to the last measurable concentration at time t in both groups (AUC0-t)
    - Testosterone plasma concentrations to characterize initial flare between Day 1 and Day 28 and time to achieve castrate level (≤50 ng/dl), in both groups
    Safety:
    - Occurrence of serious and non-serious adverse events, ECG, vital signs, physical examination and safety laboratory parameters

    Exploratory variables:
    - Performance score related to the use of the syringe through a questionnaire for the investigators.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation of the PK and PD endpoints are described in table 8.1-1 of the protocol.
    The timepoints of evaluation of safety and exploratory endpoints are described in section 20.1. of the protocol - Study visit schedule .
    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 Yes
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    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 years1
    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 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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 58
    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
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-08
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