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    Summary
    EudraCT Number:2010-019632-12
    Sponsor's Protocol Code Number:A-94-5214-178
    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:2010-08-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-019632-12
    A.3Full title of the trial
    A phase II, multicentre, open, prospective, randomised, parallel-group, pharmacodynamic equivalence study on intramuscular versus subcutaneous applications of Triptorelin pamoate (Pamorelin® LA 11.25 mg) in patients with advanced prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study investigates the new subcutaneous application of Triptorelin pamoate (Pamorelin® LA 11.25 mg) versus the intramuscular application in patients with advanced prostate cancer .
    A.3.2Name or abbreviated title of the trial where available
    PAMIS
    A.4.1Sponsor's protocol code numberA-94-5214-178
    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 SponsorIPSEN Pharma GmbH
    B.1.3.4CountryGermany
    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 supportIPSEN Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGKM Gesellschaft für Therapieforschung mbH
    B.5.2Functional name of contact pointDr. Andrea Röthler
    B.5.3 Address:
    B.5.3.1Street AddressLessingstr. 14
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80336
    B.5.3.4CountryGermany
    B.5.4Telephone number00498920912021
    B.5.5Fax number00498920902030
    B.5.6E-maila.roethler@gkm-therapieforschung.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 Pamorelin LA 11.25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDebioclinic S.A.
    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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    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 INNTRIPTORELINPAMOATE
    D.3.9.1CAS number 57773-63-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    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 Pamorelin LA 11.25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDebioclinic S.A.
    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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELINPAMOATE
    D.3.9.1CAS number 57773-63-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    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
    advanced prostate cancer (locally advanced or metastatic)
    E.1.1.1Medical condition in easily understood language
    prostate cancer with tumor stage T3-T4 or metastatic
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    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
    The main objective of the trial is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85d] for serum testosterone in patients with advanced prostate cancer.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    • Time to castration [tcast] in patients with advanced prostate cancer
    • Area under the curve [AUC1-169d] for testosterone
    • Area under the curve [AUC85-169d] for testosterone
    • Maximum concentration of serum testosterone [Cmax]
    • Time to maximum concentration of serum testosterone [tmax]
    • Number and percentage of patients attaining castrate level by day 29 and
    maintaining castration until the end of the second dosing interval without showing
    relevant escapes from castration
    • Percentage of patients with castration levels of testosterone
    • Course of PSA and testosterone levels and changes from baseline
    • Evaluate the Visual Analogue Scale (VAS) for tumour-related pain, e.g. bone pain
    • Safety profiles of IM and SC injections of triptorelin pamoate 11.25 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Provision of written informed consent prior to any study related procedures.
    (2) Male patients aged 18 years and older
    (3) Histologically or cytologically proven prostate cancer, locally advanced or
    metastatic, or rising PSA after failed local therapy, and the patient scheduled to
    receive androgen deprivation therapy
    - Definition of locally advanced: T3 or T4 or N1 with any T, M09
    - Definition of metastatic: any T, any N, M1
    (4) Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 ng/l, 4.3 nmol/l)
    measured by any laboratory or on site within the previous 6 months or at study
    start
    (5) Karnofsky performance index > 70
    (6) Expected survival ≥ 9 months
    (7) Absence of other malignancy, other than dermatological, for the previous 5 years
    E.4Principal exclusion criteria
    (1) Prior hormonal treatment for prostate cancer including finasteride, oestrogens or
    a steroidal anti–androgen within the last 6 months preceding the study or
    concomitant treatment with one or more of these substance(s)
    (2) Prior hormonal treatment for prostate cancer including GnRH agonists or
    antagonists within the last 12 months preceding the study or concomitant
    treatment with one or more of these substance(s)
    (3) Presence of another malignant neoplasm
    (4) Prior hypophysectomy or adrenalectomy
    (5) Patient who is scheduled to receive an orchiectomy during the course of this
    study
    (6) Any current use or within 6 months prior to treatment start of medications which
    are known to affect the metabolism and/or secretion of androgenic hormones:
    ketoconazole, aminoglutethimide, oestrogens and progesterone
    (7) Use of corticosteroids, except topical applications
    (8) Patient at risk of spinal cord compression or ureter obstruction
    (9) Patient with abnormal baseline findings or any other medical condition(s) that, in
    the opinion of the investigator, might jeopardise the subject’s safety or decrease
    the chance of obtaining satisfactory data needed to achieve the objective(s) of
    the study
    (10) Patient has a history of hypersensitivity to the IMP or drugs with a similar
    chemical structure
    (11) Inability to give informed consent or to comply fully with the protocol
    (12) Participation in another clinical trial within the last 30 days or simultaneous
    participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve of testosterone serum concentration between D1 and D85 [AUC1-85d].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day, Day 57, Day 85
    E.5.2Secondary end point(s)
    Area under the curve [AUC85-169d] for testosterone
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 85, Day 87, Day 113, Day 141, Day 169
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    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 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 concerned30
    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 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
    The study will be considered to have finished after the last patient has completed the last visit in the study.
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Treatment after study end is left to investigator`s discretion. A continuation of therapy after the study is possible as Pamorelin® LA 11.25 mg is available on the German market.
    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 Decision2010-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-07
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