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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2011-001193-26
    Sponsor's Protocol Code Number:C_30050_P3_02
    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:2011-08-08
    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 number2011-001193-26
    A.3Full title of the trial
    An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of the Acino goserelin 3.6 mg implant that is administered twice in two months in patients with prostate cancer and examination of goserelin and hormone levels in the blood after administration of the Acino goserelin 3.6 mg implant and the Zoladex® 3.6 mg implant in a smaller subgroup of patients.
    A.4.1Sponsor's protocol code numberC_30050_P3_02
    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 SponsorAcino Supply AG
    B.1.3.4CountrySwitzerland
    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 supportAcino Supply AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFGK Clinical Research GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressHeimeranstrasse 35
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80339
    B.5.3.4CountryGermany
    B.5.4Telephone number004989893 11934
    B.5.5Fax number004189893 11920
    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 nameGoserelin 3.6 mg Implant
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Implantation
    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 CodeSUB02400MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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 Yes
    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 3.6 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameZoladex 3.6 mg
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Implantation
    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 number3.6
    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
    Locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy
    E.1.1.1Medical condition in easily understood language
    Advanced 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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10007462
    E.1.2Term Carcinoma prostate
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males between 18 and 89 years of age at the start and for the duration of the study
    2. Diagnosis of locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy
    3. Testosterone values of >1.5 ng/mL at Screening (Visit 1)
    4. Life expectancy of at least 6 months
    5. Written informed consent

    E.4Principal exclusion criteria
    1. Hypersensitivity to Zoladex or to other gonadotropin releasing hormone (GnRH) analogs
    2. Previous androgen deprivation therapy, treatment with GnRH analogs, treatment with antiandrogens or androgen receptor blockers is not allowed within 3 months before baseline, except treatment with non-steroidal antiandrogens as described in the protocol.
    3. Concomitant treatment with any GnRH analogs. Patients who previously underwent an intermittent treatment scheme may be included if no more than 2 treatment cycles were received. A treatment cycle is defined as the continuous and repeated administration of a GnRH analog (according to the prescribing information) until a discontinuation of treatment based on the patient’s physical and / or disease status as judged by the investigator. The re-initiation of a subsequent GnRH analog administration (based on medical judgement) after the treatment discontinuation is defined as the start of a new treatment cycle.
    4. Considered for curative therapy i.e. radical prostatectomy or radiotherapy within 2 months from inclusion
    5. Cancer diagnosis within the last 5 years except prostate cancer, low grade bladder cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
    6. Uncontrolled cardiac disease, including myocardial infarction within 12 months before screening, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of ≥3, unstable angina, abnormal blood pressure, severe cardiac arrhythmias, electrolyte abnormalities, congenital long QT syndrome, or cerebrovascular disease including stroke within 3 years of screening.
    7. History of abnormal blood pressure, unless adequately controlled with conventional treatment. Normal blood pressure is defined as BP <=140/90 mm Hg and >=90/60 mm Hg for those below 80 years of age, or <=150/90 mm Hg and >=90/60 mm Hg for those above 80 years of age. NOTE: In case patients present with abnormal BP readings at Visit 1 then they may get treated for hypertension by a doctor, and return for the Visit 2 assessments. If their BP values are found acceptable at Visit 2, they can still be included in the study.
    8. Concomitant medication of class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medications as well as bupropion, moxifloxacin, and SSRIs.
    9. Uncontrolled diabetes mellitus, or HbA1c>9%, at the time of screening or diabetic complications (retinopathy, neuropathy, nephropathy, PAD) within the past year.
    10. Medical history or concurrent condition of psychiatric disorders, such as psychotic disorders and depression.
    11. Medical history of seizures, convulsions, epilepsy, central nervous system anomalies, tumors, or anticonvulsive treatment.
    12. Medical history or current condition osteoporosis.
    13. Condition of ureteric obstruction or spinal cord compression.
    14. Previous orchiectomy, adrenalectomy, or hypophysectomy
    15. Medical history of any clinically significant neurological, gastrointestinal, renal, hepatic, respiratory, endocrine, hematological, dermatological or infectious disorder or other condition including alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator (using the ECOG [Eastern Cooperative Oncology Group] performance scale; patients who have an ECOG performance status of ≥3 will be excluded).
    16. Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures
    17. Previous participation in this study
    18. Known allergy against one of the ingredients in the test or reference preparation
    19. Having used any investigational medication or medical device in the 12 weeks prior to Screening or scheduled to use another investigational medication or medical device during the study
    20. Participation in another clinical study within 30 days before screening
    21. Absence of effective contraception (i.e. use of condoms or sexual abstinence)
    22. Employee at the investigational site, relative or spouse of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Testosterone response rate defined as testosterone values sustained below castration level (0.5 ng/mL) i.e. all testosterone values at and after Day 28 until Day 56 must be < 0.5 ng/mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    At and after Day 28 until Day 56 (Days 28, 31, 35, 42, 49 and 56)
    E.5.2Secondary end point(s)
    Efficacy:
    E1 - Percentage of patients who have reached castration level of testosterone (<0.5 ng/mL) at the last visit (Day 56)
    E2 - Time course of testosterone levels on Days 28, 31, 35, 42, 49, 56
    E3 - Time after first implantation until castration level of testosterone is achieved
    E4 - Rate of patients with testosterone values sustained below 0.2 ng/mL at and after Day 28 until Day 56
    E5 - Results of clinical examination of the prostate
    E6 - Prostate-specific antigen (PSA) level

    Pharmacokinetics and luteinizing hormone/folligcle stimulating hormone (LH/FSH):
    P1 - Plasma levels of goserelin, luteinizing hormone/follicle stimulating hormone (LH/FSH) between Day 0 (first implantation) and Day 56 (last visit)

    Safety and tolerability:
    S1 - Adverse events
    S2 - Electrocardiogram (ECG) at the day of implantation, prior to implantation, and at study end
    S3 - Safety laboratory (including glucose and HbA1c)
    S4 - Vital signs, and body weight
    S5 - Local Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    E1 - Day 56
    E2 - Days 28, 31, 35, 42, 49, 56
    E3 - Day at which castration level of testosterone is achieved
    E4 - At and after Day 28 until Day 56 (Days 28, 31, 35, 42, 49 and 56)
    E5 - Day 56
    E6 - Days 28, 31, 35, 42, 49, 56

    Pharmacokinetics and luteinizing hormone/follicle stimulating hormone (LH/FSH):
    P1 - Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56

    Safety and tolerability:
    S1 - Informed consent until all follow-ups have been concluded after the end of the study
    S2 - Day 56
    S3 - Safety laboratory: Days 14, 28, 56; Glucose: Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56; HbA1c: Day 56
    S4 - Vital signs: Days 1, 2, 4, 7, 14, 21, 28, 31, 35, 42, 49, 56; body weight: Day 28, Day 56
    S5 - Days 1, 7, 28, 35, 56
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 109
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 145
    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)
    Patients will be treated according to the medical standard.
    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 Decision2011-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-15
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA