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    Summary
    EudraCT Number:2015-004469-10
    Sponsor's Protocol Code Number:GETHI-2016-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-01
    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 number2015-004469-10
    A.3Full title of the trial
    Open label phase II clinical trial of enzalutamide in metastatic or advanced non-resectable granulosa cell ovarian tumors. GreKo III study.
    Ensayo clínico fase II abierto de enzalutamida en cáncer de la granulosa ovárica avanzado no resecable o metastásico. Estudio GreKo III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Enzalutamide in granulosa cell ovarian tumors.
    Estudio de enzalutamida en tumos ováricos de células de la granulosa.
    A.3.2Name or abbreviated title of the trial where available
    GREKO III
    A.4.1Sponsor's protocol code numberGETHI-2016-01
    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 SponsorGrupo Español de Tumores Huérfanos e Infrecuentes (GETHI)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASTELLAS PHARMA S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES S.L.
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAv. Antonio López 16, 1ºA
    B.5.3.2Town/ cityPinto
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804100
    B.5.5Fax number+34918169172
    B.5.6E-mailana.moreno@apices.es
    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 AuthorisationSpain
    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 codeENZALUTAMIDE
    D.3.9.3Other descriptive nameENZALUTAMIDE
    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
    Advanced ovarian granulosa unresectable or metastatic tumor
    Cáncer de la granulosa ovárica avanzado no resecable o metastásico
    E.1.1.1Medical condition in easily understood language
    Ovarian granulosa tumor
    Cáncer de la granulosa ovárica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of enzalutamide in advanced ovarian granulosa unresectable or metastatic tumor by the overall response rate (ORR), defined as the percentage of patients achieving partial or complete response according to RECIST 1.1 criteria, by means of radiological evaluation.
    Evaluar la eficacia de enzalutamida en tumores de la granulosa ovárica avanzado no resecable o metastásico mediante la tasa de respuesta global (TRG), definida como el porcentaje de pacientes que alcanzan una respuesta parcial o completa según los criterios RECIST 1.1, mediante evaluación radiológica.
    E.2.2Secondary objectives of the trial
    - To evaluate the clinical benefit rate, defined as the stabilization of disease for at least 6 months, plus the sum of partial and complete responses according to RECIST 1.1 criteria, by means of radiological evaluation.
    - To evaluate progression-free survival (PFS), defined as time from the administration of the first dose of treatment to the progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause.
    - To evaluate overall survival (OS), defined as the time since the administration of the first dose of treatment until the death of the patient for any cause.
    - To determine the toxicity profile of enzalutamide in the population of the study.
    - Evaluar la tasa de beneficio clínico, definida como estabilización de la enfermedad durante al menos 6 meses, más la suma de respuestas parciales y completas según los criterios RECIST 1.1, mediante evaluación radiológica.
    - Evaluar la supervivencia libre de progresión (SLP), definida como el tiempo desde la administración de la primera dosis del tratamiento hasta la progresión de la enfermedad según los criterios RECIST 1.1 o la muerte de la paciente por cualquier causa.
    - Evaluar la supervivencia global (SG), definida como el tiempo desde la administración de la primera dosis del tratamiento hasta la muerte de la paciente por cualquier causa.
    - Determinar el perfil de toxicidad de enzalutamida en la población del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have given written informed consent
    2. Women aged 18 years or over
    3. ECOG ≤ 1
    4. Diagnosis of histologically confirmed ovarian granulosa carcinoma.
    5. Availability of sufficient biopsy material for confirmation of the diagnosis by a centralized pathologist and determination of the mutation FOXL2402C→ G(C134W). If this material is not available, principal investigator of the study will confirm eligibility of the patient.
    6. Metastatic or unresectable disease
    7. Radiologically measurable disease. In case you there is not measurable disease, principal investigator of the study will confirm eligibility of the patient.
    8. Life expectancy ≥ 12 weeks.
    9. Patients with adequate hepatic function, defined by:
    - AST and ALT serum values ​​≤ 3 x ULN (except in the presence of metastasis in which case values ​​≤ 5 x ULN will be allowed)
    - Total bilirubin values ​​≤1,5 ​​x ULN
    10. Patients with adequate bone marrow function, defined by:
    - Absolute neutrophil count ≥1.5 x 109 / L
    - Platetets ≥100 x 109/L,
    - Hemoglobine ≥9 g/dL.
    11. Patients with adequate renal function: serum creatinine ≤1,5 x LSN
    12. Absence of any disability to follow the study protocol.
    13. Women childbearing potential who are sexually active, not undergoing hysterectomy or double adnexectomy, should follow the following contraceptive indications:
    - Negative Pregnancy Test in serum or urine in the 72 hours before the start of treatment.
    - Use of a medically accepted method of contraception during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment.
    1. Pacientes que hayan otorgado su consentimiento informado por escrito
    2. Mujeres con edad igual o superior a 18 años
    3. ECOG ≤1
    4. Diagnóstico de carcinoma de la granulosa ovárica confirmado histológicamente
    5. Disponibilidad de material de biopsia suficiente para la confirmación del diagnóstico por un patólogo centralizado y determinación de la mutación FOXL2 402C→G (C134W). En caso de no disponerse de este material, se consultará con el investigador coordinador la elegibilidad del caso.
    6. Enfermedad metastásica o no resecable
    7. Enfermedad medible radiológicamente. En caso de no presentar enfermedad medible, se consultará con el investigador coordinador la elegibilidad del caso.
    8. Esperanza de vida ≥ 12 semanas.
    9. Pacientes con adecuada función hepática, definida por:
    - Valores séricos de AST y ALT ≤ 3 x LSN (salvo en presencia de metástasis en cuyo caso se permitirán valores ≤ 5 x LSN)
    - Valores de bilirrubina total ≤1,5 x LSN
    10. Pacientes con adecuada función de la médula ósea, definida por:
    - Recuento absoluto de neutrófilos ≥1,5 x 109/L,
    - Plaquetas ≥100 x 109/L,
    - Hemoglobina ≥9 g/dL.
    11. Pacientes con función renal adecuada: creatinina sérica ≤1,5 x LSN
    12. Ausencia de cualquier impedimento para el cumplimiento del protocolo del estudio
    13. Las mujeres en edad fértil sexualmente activas, no sometidas a histerectomía o doble anexectomía, deben seguir las siguientes indicaciones sobre contracepción:
    - Prueba del embarazo en suero u orina negativa en las 72 horas anteriores al inicio del tratamiento.
    - Utilización de un método anticonceptivo médicamente aceptado durante: los 2 meses anteriores al inicio del tratamiento del estudio, durante el estudio y hasta 3 meses después de la última dosis del tratamiento.
    E.4Principal exclusion criteria
    1. Patients with another primary tumor 2 years before beginning the drug under study, with the exception of adequetely treated or totally surgically removed cervical carcinoma in-situ or basaliome or superficial bladder carcinoma.
    2. Patients who have received radical radiotherapy ≤ 4 weeks prior to the start of study treatment or who have not recovered from
    toxicities of radiotherapy. Palliative radiation therapy for painful bone lesions bone is allowed up to 14 days prior to the beginning of the study treatment
    3. History of seizures or any conditions that may predispose to suffer them.
    4. Current or previously treated brain metastases or disease leptomeningea.
    5. Patients with cardiac insufficiency or heart disease clinically significant ncluding any of the following:
    - History or presence of uncontrolled severe ventricular arrhythmias.
    - Clinically significant resting bradycardia.
    - Any of the following diseases within 6 months prior to the start of the study drug Myocardial infarction (MI), severe or unstable angina,
    coronary revascularization, congestive cardiac insufficiency (CCI), cerebrovascular accident (CVA), transient ischemic accident (TIA)
    6. Patients with altered gastrointestinal function or with gstric disease that significantly alters the absorption of enzalutamide, such as
    for example: severe ulcer diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the
    small bowel or inability to swallow oral medication. The previous partial or total gastrectomy is not an exclusion criterion.
    7. Diagnosis of human immunodeficiency virus (HIV) infection.
    8. Pregnant or lactating women.
    9. Women of childbearing potential not using an effective contraceptive method.
    10. Patients who do not want or can follow the study protocol.
    1. Pacientes con otro tumor primario 2 años antes de comenzar con el fármaco en estudio, con la excepción de carcinoma de cuello de útero in-situ adecuadamente tratado o extirpado completamente o basalioma o carcinoma vesical superficial.
    2. Pacientes que hayan recibido radioterapia radical ≤ 4 semanas antes de comenzar el tratamiento en estudio o que no se hayan recuperado de las toxicidades de la radioterapia. La radioterapia paliativa para las lesiones dolorosas de hueso está permitida hasta 14 días previos al comienzo del tratamiento en estudio.
    3. Antecedentes de convulsiones o cualquier condición que pueda predisponer a sufrirlas.
    4. Metástasis cerebrales actuales o previamente tratadas o enfermedad leptomeningea.
    5. Pacientes con insuficiencia cardiaca o enfermedad cardiaca clínicamente significativas, incluyendo cualquiera de las siguientes:
    - Historia o presencia de arritmias ventriculares severas no controladas.
    - Bradicardia en reposo clínicamente significativa.
    - Cualquiera de las siguientes enfermedades dentro de los 6 meses previos al comienzo del fármaco en estudio: Infarto de miocardio (IM), angina severa o inestable, revascularización coronaria, insuficiencia cardiaca congestiva (ICC), accidente cerebrovascular (ACV), accidente isquémico transitorio (TIA).
    6.Pacientes con alteración de la función gastrointestinal o con enfermedad gástrica que altere significativamente la absorción de enzalutamida, como por ejemplo: enfermedades ulcerosas graves, náuseas descontroladas, vómitos, diarrea, síndrome de malabsorción, resección extensa (>1m) del intestino delgado o incapacidad para tragar medicación oral. La gastrectomía previa parcial o total no es un criterio de exclusión.
    7.Diagnóstico de infección por el virus de la inmunodeficiencia humana (VIH).
    8. Mujeres embarazadas o en lactancia.
    9. Mujeres en edad fértil que no empleen un método anticonceptivo efectivo.
    10. Pacientes que no quieran o no puedan cumplir con el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Overall Rate Response (ORR)
    Tasa de respuesta global (TRG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Achivement of partial or complete response according to RECIST 1.1 criteria, by means of radiological evaluation.
    Momento en que se alcanza respuesta parcial o completa según los criterios RECIST 1.1, mediante evaluación radiológica.
    E.5.2Secondary end point(s)
    - Clinical Benefit Rate
    - Progression Free Survival (PFS)
    - Overall Survival (OS)
    - Toxicity to Enzalutamide
    - Tasa de beneficio clínico
    - Supervivencia libre de progresión (SLP)
    - Supervivencia global (SG)
    - Toxicidad de enzalutamida
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Clinical Benefit Rate, achivement of stabilization of the disease during at least 6 months and achievement of both partial and complete responses
    - Progression Free Survival (PFS), achivement of progression diseases since first administration of the study drug
    - Overall Survival (OS), achivement of the death of the patient for any cause since first administration of the study drug
    - Toxicity to Enzalutamide, since first administration of the study drug until the end of the study treatment.
    - Tasa de beneficio clínico, alcanzar estabilización de la enfermedad durante al menos 6 meses, más la suma de respuestas parciales y completas
    - Supervivencia libre de progresión (SLP), alcanzar progresion de la enfermedad desde la administración de la primera dosis del tratamiento del estudio.
    - Supervivencia global (SG), alcanzar el fallecimiento por cualquier causa desde la administración de la primera dosis del tratamiento del estudio.
    - Toxicidad de enzalutamida registrada desde la primer administración del tratamiento del estudio hasta la finalización del mismo.
    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 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) 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 concerned8
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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 Decision2018-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-11-24
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