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    Summary
    EudraCT Number:2008-003931-19
    Sponsor's Protocol Code Number:FE200486CS29
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-003931-19
    A.3Full title of the trial
    Ensayo abierto, multicéntrico y no controlado para investigar la pauta de administración de degarelix una vez al mes como privación intermitente de andrógenos durante un ciclo de tratamiento en pacientes con cáncer de próstata que requieren tratamiento de privación androgénica.

    An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One Cycle in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy.
    A.3.2Name or abbreviated title of the trial where available
    FE200486CS29
    A.4.1Sponsor's protocol code numberFE200486CS29
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameDegarelix 40mg/ml
    D.3.2Product code FE200486
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDegarelix
    D.3.9.1CAS number 214766-78-6
    D.3.9.3Other descriptive nameFE200486
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameDegarelix 20mg/ml
    D.3.2Product code FE200486
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDegarelix
    D.3.9.1CAS number 214766-78-6
    D.3.9.3Other descriptive nameFE200486
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Cáncer de próstata.

    Prostate Cancer.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ?Evaluar el tiempo hasta que la concentración de PSA sea >4 ng/ml tras el final de un período de inducción con degarelix (7 tratamientos mensuales) en pacientes con cáncer de próstata.
    E.2.2Secondary objectives of the trial
    ?Evaluar el tiempo hasta una concentración de PSA >4 ng/ml en subgrupos de pacientes (definidos por tratamiento previo con intención curativa, puntuación de Gleason, concentraciones basales de PSA y testosterona y concentración de PSA al final del período de tratamiento de inducción).
    ?Determinar el tiempo hasta el regreso al límite inferior de la normalidad ajustado en función de la edad o concentración basal de testosterona una vez terminado un período de inducción con degarelix (7 tratamientos mensuales).
    ?Evaluar concentraciones plasmáticas de degarelix durante el tratamiento de inducción con degarelix y períodos de descanso.
    ?Evaluar la calidad de vida específica de la enfermedad durante el tratamiento de inducción con degarelix y períodos de descanso.
    ?Evaluar la función sexual durante el tratamiento de inducción con degarelix y períodos de descanso.
    ?Evaluar la seguridad y le tolerabilidad durante el tratamiento de inducción con degarelix y períodos de descanso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.El paciente ha otorgado su consentimiento informado por escrito antes de someterse a cualquier actividad relacionada con el estudio. Las actividades relacionadas con el estudio se definen como los procedimientos que no se habrían llevado a cabo como parte del tratamiento normal del paciente.
    2.El paciente tiene un adenocarcinoma de próstata (en cualquier estadio) confirmado histológicamente (clasificado según Gleason) y necesita tratamiento de privación de andrógenos.
    3.A. Pacientes con cáncer de próstata avanzado localmente o metastásico
    La concentración de selección del PSA (medido en un laboratorio central) debe ser >4 ng/ml y ?50 ng/ml.
    3. B. Pacientes con cáncer de próstata localizado o sometidos previamente a tratamiento con intención curativa y con el PSA en aumento. El tiempo de duplicación del PSA (según los registros del paciente en el centro del ensayo) debe ser <24 meses. No se exige un nivel de PSA mínimo, y el máximo debe ser ?50 ng/ml.
    4.Pacientes varones de 18 años en adelante.
    5.El paciente presenta una puntuación ECOG (Eastern Cooperative Oncology Group) ?2.
    6.El paciente tiene una esperanza de vida de 24 meses como mínimo.
    E.4Principal exclusion criteria
    1.El paciente ha recibido o recibe tratamiento hormonal del cáncer de próstata (castración quirúrgica u otra manipulación hormonal, a saber, agonistas del receptor de GnRH, antagonistas del receptor de GnRH, antiandrogénicos, estrógenos, inhibidores de la 5-alfa reductasa. No obstante, en el caso de los pacientes sometidos a prostatectomía o a radioterapia con fines curativos, se acepta una duración máxima del tratamiento hormonal neoadyuvante/adyuvante de 6 meses. Este tratamiento debe haber terminado al menos 6 meses antes de la visita de selección.
    2.Se considera que el paciente es candidato al tratamiento curativo, es decir, prostatectomía radical o radioterapia.
    3.El paciente presenta antecedentes de asma grave no controlada, reacciones anafilácticas o urticaria y/o angioedema intensos.
    4.El paciente es hipersensible a cualquiera de los componentes del medicamento en investigación.
    5.El paciente ha tenido cáncer en los cinco últimos años, excepto el cáncer de próstata y el carcinoma cutáneo basocelular o epidermoide extirpado por vía quirúrgica.
    6.El paciente presenta una enfermedad hepática y/o biliar clínicamente significativa o se sospecha que la padece.
    7.El paciente presenta cualquier alteración analítica significativa que, en opinión del investigador, podría afectar a la salud del paciente o al resultado del ensayo.
    8.El paciente tiene un trastorno clínicamente significativo (aparte del cáncer de próstata), como por ejemplo, enfermedad renal, hematológica, digestiva, endocrina, cardíaca, neurológica o psiquiátrica, y abuso del alcohol o de las drogas, o cualquier otro trastorno que pueda afectar a la salud del paciente o al resultado del ensayo, en opinión del investigador.
    9.El paciente presenta una incapacidad mental o problemas de idioma que le impiden comprender debidamente o cooperar con el ensayo.
    10.El paciente ha recibido un fármaco experimental en los 28 días previos a la visita de selección o en un plazo mayor si se considera que puede influir en el resultado del presente ensayo.
    11.El paciente ya ha participado en otro ensayo de degarelix.
    E.5 End points
    E.5.1Primary end point(s)
    ?Mediana y variabilidad entre pacientes del tiempo hasta una concentración de PSA >4 ng/ml tras 7 inyecciones mensuales de tratamiento de inducción con degarelix.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Al final del ensayo, se ofrecerá al paciente la posibilidad de recibir tratamiento con degarelix de acuerdo con un protocolo de seguimiento hasta que se comercialice el medicamento, o bien se le recetará otro tratamiento. Esto será también aplicable a pacientes que no presenten una respuesta adecuada del PSA al final del periodo de tratamiento de inducción.
    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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-10
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    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
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