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    Summary
    EudraCT Number:2021-005719-29
    Sponsor's Protocol Code Number:D-FR-52014-245
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-06
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005719-29
    A.3Full title of the trial
    An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue
    Estudio abierto, multicéntrico y de un solo grupo, para evaluar la eficacia y la seguridad de una formulación semestral de triptorelina administrada por vía subcutánea a participantes con cáncer de próstata localmente avanzado y/o metastásico, previamente tratados y sometidos a castración farmacológica con un análogo de la GnRH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of triptorelin when given every 6-months under the skin to adult males
    with cancer in the prostate
    Efectos de la triptorelina en su administración subcutánea semestral a varones adultos con cáncer de próstata
    A.4.1Sponsor's protocol code numberD-FR-52014-245
    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 SAS
    B.1.3.4CountryFrance
    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 SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Bioinnovation
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address102 Park Drive
    B.5.3.2Town/ cityMilton Park, Oxfordshire
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailmuhammad.shoaib.ext@ipsen.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 Yes
    D.2.1.1.1Trade name Decapeptyl
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNTRIPTORELIN
    D.3.9.1CAS number 57773-63-4
    D.3.9.3Other descriptive nameTriptorelin embonate (pamoate)
    D.3.9.4EV Substance CodeSUB11324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 Yes
    D.3.11.13.1Other medicinal product typeTriptorelin is an agonist analogue of natural GnRH.
    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
    cáncer de próstata
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level LLT
    E.1.2Classification code 10085679
    E.1.2Term Locally advanced prostate cancer
    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 evaluate the efficacy of triptorelin
    embonate 22.5 mg 6-month formulation
    administered subcutaneously in maintaining
    serum testosterone castrate levels in
    participants with advanced prostate cancer
    previously treated and castrated with a
    GnRH analogue.
    Evaluar la eficacia de la formulación semestral de
    triptorelina embonato 22,5 mg administrada por
    vía subcutánea para mantener los niveles de
    castración de testosterona sérica en participantes
    con cáncer de próstata avanzado, previamente
    tratados y sometidos a castración farmacológica
    con un análogo de la GnRH.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation
    administered subcutaneously on castration;
    - To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation
    administered subcutaneously on testosterone levels <0.694 nmol/L (20 ng/dL);
    - To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously to suppress the ‘acute-on-chronic’ effect following the administration of the second dose;
    - To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in the maintenance of PSA;
    - To demonstrate the safety profile of triptorelin embonate 22.5 mg 6-month
    formulation administered subcutaneously;
    - Evaluar la eficacia de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea en cuanto a la castración;
    - Evaluar la eficacia de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea a juzgar por niveles de testosterona <0,694 nmol/L (20 ng/dl);
    - Demostrar el efecto de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea en cuanto a la supresión de la reagudización tras la administración de la segunda dosis;
    - Demostrar el efecto de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía
    subcutánea en cuanto al mantenimiento del PSA;
    - Demostrar el perfil de seguridad de la formulación semestral de triptorelina embonato 22,5 mg administrada por vía subcutánea
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent.
    2. Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen deprivation therapy.
    3. Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy).
    4. Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening.
    5. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 (see Appendix 10.4).
    6. Has a life expectancy of >18 months.
    7. Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention.
    8. Capable of giving signed informed consent as described in Appendix 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
    1. Varón, de como mínimo 18 años de edad en el momento de firma del consentimiento informado.
    2. Cáncer de próstata, confirmado histológica o citológicamente, con elevación del PSA tras fracaso de tratamiento local, o enfermedad metastásica, o que precisa radioterapia y que es candidato para tratamiento de deprivación androgénica a largo plazo (es decir, >1 año).
    3. Necesidad de tratamiento con un análogo de la GnRH durante un mínimo de 18 meses, de los cuales ya ha recibido un mínimo de 3 meses de tratamiento con un análogo de la GnRH antes de la selección. (Nota: el participante deberá recibir el tratamiento del estudio el Día 1 de acuerdo a la pauta de tratamiento de su terapia recibida previa con el análogo de la GnRH).
    4. Niveles séricos de testosterona <1,735 nmol/L (50 ng/dL) en la selección.
    5. Puntuación del estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1 (véase el Apéndice 10.4).
    6. Esperanza de vida >18 meses.
    7. Varón participante conforme en que, si su pareja pudiera quedarse embarazada (aunque es algo extremadamente improbable en esta población del estudio), ambos utilizarán un método anticonceptivo efectivo. El participante debe estar de acuerdo en utilizar métodos anticonceptivos durante todo el estudio y los 9 meses siguientes a la última dosis del tratamiento del estudio .
    8. Capacidad de firmar el consentimiento informado, tal como se describe en el Apéndice 10.1, lo que incluye su cumplimiento con los requisitos y las restricciones que se señalan en dicho documento de consentimiento informado (DCI) y en este protocolo.
    E.4Principal exclusion criteria
    Medical conditions
    1.Presence of another neoplastic lesion or brain metastases.
    2.Metastatic hormone-sensitive prostate cancer with high tumour burden
    3.Metastatic castration-resistant prostate cancer
    4.Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator.
    Prior/concomitant therapy
    5.Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months
    6.Planned intermittent scheme of GnRH analogue
    7.Use of any other therapy for prostate cancer during the study (e.g. chemotherapy)
    8.Prior hypophysectomy or adrenalectomy
    Prior/concurrent clinical study experience
    9.Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research.
    Diagnostic assessments
    10.Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range)
    Other exclusions
    11.Any concomitant disorder or resulting therapy that is likely to interfere with participant’s compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator.
    12.Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes
    13.Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues.
    14.Known active use of recreational drug or alcohol dependence in the opinion of the investigator
    15.Inability to give informed consent or to comply fully with the protocol.
    Procesos médicos
    1. Presencia de otro tumor o metástasis cerebrales .
    2. Cáncer de próstata metastásico hormono-sensible de elevada carga tumoral
    3. Cáncer de próstata metastásico resistente a la castración
    4. Todo trastorno concomitante o terapia derivada que, en opinión del investigador, es probable que pueda interferir con el cumplimiento del tratamiento o con el estudio por el participante.
    Tratamiento previo/concomitante
    5. Uso de finasterida (Proscar®) o dutasteride (Avodart®/Avolve®) en los 6 últimos meses
    6. Pauta intermitente programada con un análogo de la GnRH
    7. Uso de cualquier otro tratamiento para el cáncer de próstata durante el estudio (por ejemplo, quimioterapia )
    8. Hipofisectomía o adrenalectomía previas.
    Participación previa / concomitante en estudios clínicos
    9. Participación en otro estudio con un fármaco experimental en el plazo de los 3 meses anteriores a la firma del consentimiento informado o de 5 semividas de dicho medicamento experimental (eligiéndose el mayor de estos periodos), o en cualquier otro tipo de investigación médica .
    Otros diagnósticos
    10. Insuficiencia renal o hepática severas (creatinina >2 veces la normalidad, aspartato aminotransferasa y alanina aminotransferasa >3 veces la normalidad).
    Otros criterios de exclusión
    11. Toda enfermedad concomitante o tratamiento derivado de ella que, en opinión del investigador, pudiera probablemente interferir con el cumplimiento del participante, la administración subcutánea del fármaco o el estudio .
    12. Antecedente de prolongación del QT o uso concomitante de medicamentos que se sabe que prolongan el intervalo QT o con riesgo conocido de torsades de pointes
    13. Conocimiento de hipersensibilidad a la triptorelina o cualquiera de sus excipientes, a la GnRH o a otros agonistas/análogos de la GnRH.
    14. Conocimiento de consumo activo de drogas o dependencia del alcohol, en opinión del investigador
    15. Incapacidad de otorgar el consentimiento informado o de cumplir adecuadamente con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants maintaining castrate levels of serum testosterone during
    the study (maintenance of castration defined as testosterone <1.735 nmol/L (50 ng/dL) at Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337)
    Porcentaje de participantes que mantengan niveles de castración de testosterona sérica durante el
    estudio (mantenimiento de la castración definido
    como testosterona <1,735 nmol/l (50 ng/dl) el día
    29, día 85, día 141, día 169, día 253, día 309 y día
    337)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.1
    Por favor refiérase a E.5.1
    E.5.2Secondary end point(s)
    - Percentage of participants castrated at each
    timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337
    (castration defined as testosterone <1.735 nmol/L (50 ng/dL)).
    - Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL) during the study.
    - Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL) at each timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337.
    - Percentage of participants castrated on Day 3 and Day 7 after each injection administered on Day 1 and Day 169 (castration defined as testosterone
    <1.735 nmol/L (50 ng/dL)).
    - Percent change in PSA from baseline (prior to injection) at Day 169 and Day 337 (Percent change in PSA defined as the absolute value of difference between the PSA values at Day 169 and Day 337 and the baseline value divided by the baseline value).
    - Incidence of TEAEs (including local tolerability) throughout the study i.e. up to
    Day 337.
    - Change from baseline in clinical safety laboratory parameters (blood chemistry and haematology) at Day 337
    - Change from baseline in physical examination at Day 169 and Day 337
    - Change from baseline in ECG at Day 337
    - Change from baseline in vital signs (blood pressure and heart rate) at each visit up to Day 337
    - Porcentaje de participantes con niveles de castración en cada momento de evaluación, esto es, día 29, día 85, día 141, día 169, día 253, día 309 y día 337 (castración definida como testosterona <1,735 nmol/l (50 ng/dl) .
    - Porcentaje de participantes con un nivel de testosterona sérica <0,694 nmol/L (20 ng/dl) durante el estudio.
    - Porcentaje de participantes con un nivel de testosterona sérica <0,694 nmol/L (20 ng/dl) en cada momento de evaluación, esto es, día 29, día 85, día 141, día 169, día 253, día 309 y día 337.
    - Porcentaje de participantes con niveles de castración el día 3 y el día 7 después de cada inyección administrada el día 1 y el día 169 (castración definida como testosterona <1,735 nmol/l (50 ng/dl))
    - Cambio porcentual del PSA frente al momento basal (antes de la inyección) el día 169 y el día 337 (cambio porcentual del PSA definido como el valor absoluto de la diferencia entre los valores de PSA el día 169 y el día 337 y el valor basal, dividida por el valor basal)
    - Incidencia de TEAE (incluida la tolerabilidad local) a lo largo del estudio, es decir, hasta el día 337
    - Cambio frente al momento basal en los parámetros de laboratorio de seguridad (bioquímica sérica y hematología) el día 337
    - Cambio frente al momento basal en la exploración física el día 169 y el día 337
    - Cambio frente al momento basal en el ECG el día 337
    - Cambio frente al momento basal en las constantes vitales (presión arterial y frecuencia cardiaca) en cada visita hasta el día 337
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2
    Por favor refiérase a E.5.2
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    LPLV
    última visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days28
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 153
    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
    Ninguno
    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 Decision2022-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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