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    Summary
    EudraCT Number:2016-001694-32
    Sponsor's Protocol Code Number:9785-CL-0123
    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:2016-09-30
    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 number2016-001694-32
    A.3Full title of the trial
    A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
    Estudio de fase II abierto de extensión para sujetos con cáncer de próstata que han participado anteriormente en un estudio clínico con enzalutamida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to provide access to continued treatment for subjects with prostate cancer who are currently participating in an enzalutamide clinical study
    dar acceso a tratamiento continuado para los sujetos que están participando actualmente en un estudio clínico de enzalutamida
    A.3.2Name or abbreviated title of the trial where available
    Protocol 9785-CL-0123
    A.4.1Sponsor's protocol code number9785-CL-0123
    A.5.4Other Identifiers
    Name:INDNumber:74,563
    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 SponsorAstellas Pharma Global Development, Inc.
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455050
    B.5.5Fax number0031715455051
    B.5.6E-mailastellas.registration@astellas.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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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
    metastatic castration-resistant prostate cancer
    Cáncer de próstata metastásico resistente a la castración
    E.1.1.1Medical condition in easily understood language
    cancer of the prostate
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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 objective of the study is to provide access to continued treatment for subjects who are currently participating in an enzalutamide clinical study for their prostate cancer and who are continuing to derive clinical benefit based on the assessment of the investigator.
    El objetivo del estudio es dar acceso a tratamiento continuado para los sujetos que están participando actualmente en un estudio clínico de enzalutamida patrocinado por Astellas o Medivation para su cáncer de próstata y que continúan obteniendo un beneficio clínico según la evaluación del investigador
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. IRB/ IEC approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act authorization for the United States sites] must be obtained from the subject prior to any study-related procedures.
    2. Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and based on the investigator’s assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
    3. Subjects are able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator’s assessment a change is needed to the subject’s regimen approval (e.g., dose change in androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
    4. Subject is able to swallow enzalutamide capsules and comply with study requirements.
    5. Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration.
    Two acceptable forms of birth control include:
    ‡ Condom (barrier method of contraception), AND
    † In addition to a condom, 1 of the following acceptable forms of contraception is required:
    ● Established use of oral, injected or implanted hormonal methods of contraception
    ● Placement of an intrauterine device or intrauterine system
    ● Barrier methods of contraception: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    ● Tubal ligation
    ● Vasectomy or other surgical castration prior to initial screening.
    6. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
    7. Subject agrees not to participate in another interventional study while on treatment.
    Waivers to the inclusion criteria will NOT be allowed
    El sujeto es elegible para el estudio si se cumple lo siguiente:
    1. Debe obtenerse el consentimiento informado por escrito y aprobado por el CRI/CEI y la declaración de privacidad según las regulaciones nacionales [p. ej.: se debe obtener la autorización de la Ley de Portabilidad y Seguridad de los seguros de Salud en los centros de Estados Unidos] del sujeto antes de realizar cualquier procedimiento relacionado con el estudio.
    2. El sujeto debe estar recibiendo actualmente enzalutamida para el cáncer de próstata en un estudio patrocinado por Astellas o por Medivation y, según la evaluación del investigador, beneficio del tratamiento continuado. Los sujetos que están participando en ensayos iniciados por un investigador no son elegibles.
    3. Los sujetos pueden continuar el régimen de tratamiento que estaban recibiendo en el estudio anterior. Si según la evaluación del investigador, es necesario un cambio en el régimen del sujeto [p. ej.: cambio de dosis en una Terapia de Privación Androgénica (TPA) o abandonar una terapia combinada], se requerirá la aprobación del monitor médico antes de la inclusión.
    4. El sujeto puede tragar las capsulas de enzalutamida y cumplir los requisitos del estudio.
    5. El sujeto y su pareja de sexo femenino en edad fértil deben continuar usando 2 métodos anticonceptivos aceptables, de las cuales 1 debe ser muy efectiva † y 1 debe ser un método de barrera ‡ durante el estudio y hasta 3 meses después de la administración final de enzalutamida.
    Dos métodos anticonceptivos aceptables incluyen:
    ‡ Condón (método anticonceptivo de barrera), Y
    †Además del condón, 1 de los siguientes métodos anticonceptivos aceptables:
    ● Uso establecido de métodos anticonceptivos hormonales orales, inyectables o implantados
    ● Colocación de un dispositivo intrauterino o sistema intrauterino
    ● Métodos anticonceptivos de barrera: tapón oclusivo (diafragma o capuchón cervical/de bóveda) con espuma/gel/película/crema/supositorio espermicida
    ● Ligadura de trompas
    ● Vasectomía u otra castración quirúrgica antes de la selección inicial.
    6. El sujeto acepta evitar la donación de esperma durante el estudio y por lo menos 3 meses después de la administración final de enzalutamida.
    7. El sujeto acepta no participar en otro estudio intervencional mientras esté en tratamiento.
    NO se permitirán excepciones a los criterios de inclusión
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are enrolling from.
    2. Subject requires treatment with or plans to use a strong CYP3A4 inducers or strong CYP2C8 inhibitors and using any narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2C9) and CYP2C19 or investigational agents.
    ● New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment
    ● Investigational therapy other than enzalutamide
    3. Subject is participating in an investigator-initiated interventional trial and receiving enzalutamide.
    4. Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.
    Waivers to the exclusion criteria will NOT be allowed.
    Se podrá excluir al sujeto de participar si se cumple alguna de las siguientes situaciones:
    1.El sujeto cumple alguno de los criterios de retirada o progresó en el estudio clínico de enzalutamida actual desde el cual será incluido.
    2.El sujeto requiere tratamiento con o planea usar inductores potentes de CYP3A4 o inhibidores potentes de CYP2C8 y está usando fármacos de margen terapéutico estrecho que son metabolizados por CYP3A4, CYP2C9 y CYP2C19 o los agentes en fase de investigación.
    ●Nueva terapia sistémica para su cáncer (se permite la terapia de radiación paliativa). El tratamiento con agentes administrados durante estudios previos que ha sido interrumpido y después reiniciado durante este estudio no constituye un tratamiento nuevo.
    ●Terapia en fase de investigación distinta a la enzalutamida
    3.El sujeto está participando en un ensayo intervencional iniciado por un investigador y está recibiendo enzalutamida.
    4.El sujeto tiene una enfermedad concurrente, infección o condición comórbida que interfiere con la capacidad del sujeto para participar en el estudio, que supone un riesgo indebido para el sujeto o que complica la interpretación de los datos en opinión del investigador.
    NO se permitirán excepciones a los criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    na
    na
    E.5.1.1Timepoint(s) of evaluation of this end point
    na
    E.5.2Secondary end point(s)
    na
    na
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned1
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Chile
    Czech Republic
    Denmark
    France
    Georgia
    Germany
    Moldova, Republic of
    Netherlands
    Russian Federation
    South Africa
    Spain
    United Kingdom
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 204
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 272
    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)
    NA
    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 Decision2016-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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