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    Summary
    EudraCT Number:2013-003128-35
    Sponsor's Protocol Code Number:GETHI-2013-01
    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:2014-03-13
    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 number2013-003128-35
    A.3Full title of the trial
    Open label phase II clinical trial of Orteronel (TAK-700) in metastatic or advanced non-resectable granulosa cell ovarian tumors. The Greko II study.
    Ensayo clínico fase II abierto de Orteronel (TAK-700) en cáncer de la granulosa ovárica avanzado no resecable o metastásico. Estudio GreKo II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Orteronel (TAK-700 study) in granulosa cell ovarian tumors.
    Estudio de Orteronel (TAK-700) en tumores ováricos de células de la granulosa.
    A.3.2Name or abbreviated title of the trial where available
    GREKO II
    A.4.1Sponsor's protocol code numberGETHI-2013-01
    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 supportTAKEDA
    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 Operatios Department
    B.5.3 Address:
    B.5.3.1Street AddressSalamanca, 7
    B.5.3.2Town/ cityTorrejón de la Calzada (MADRID)
    B.5.3.3Post code28991
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@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 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 nameOrteronel
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNORTERONEL
    D.3.9.2Current sponsor codeTAK-700
    D.3.9.3Other descriptive nameORTERONEL
    D.3.9.4EV Substance CodeSUB126331
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 or advanced non-resectable granulosa cell ovarian tumors
    Tumores ováricos de células de la granulosa metastásicos o avanzados irresecables
    E.1.1.1Medical condition in easily understood language
    Granulosa cell ovarian tumors
    Tumores ováricos de células de la granulosa
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10057376
    E.1.2Term Ovarian granulosa-theca cell tumour
    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
    To assess the efficacy in terms of clinical benefit rate of orteronel in metastatic or non-resectable locally advanced granulosa cell ovarian tumors
    Evaluar la eficacia en términos de la tasa de beneficio clínico de orteronel en tumores ováricos de células de la granulosa metastásicos o localmente avanzados irresecables
    E.2.2Secondary objectives of the trial
    - Assess Overall Response Rate (ORR) defined as the sum of patients who achieve a partial or complete response by RECIST 1.1 criteria.
    - Assess Progression Free Survival (PFS) defined as the time from the administration of the first dose of treatment to disease progression or death from any cause.
    - Assess Overall Survival (OS) defined as the time from first dose of treatment to patient death from any cause
    - Determine the impact of Orteronel in reducing sex hormone overproduction in patients, within the study population, who present hormonal overproduction at baseline
    - Determine the toxicity profile of Orteronel (TAK-700) in the study population
    - Evaluar la tasa de respuesta global (TRG), definida como la suma de las pacientes que alcanzan una respuesta parcial o completa según los criterios RECIST 1.1.
    - 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 o la muerte de la paciente por cualquier causa.
    - Evaluar la supervivencia global (SG) definida como el tiempo desde la primera dosis del tratamiento hasta la muerte de la paciente por cualquier causa
    - Determinar el impacto de orteronel en la reducción de la sobreproducción de hormonas sexuales en las pacientes, en la población del estudio, que presenten sobreproducción hormonal en el periodo basal.
    - Determinar el perfil de toxicidad de Orteronel (TAK-700) en la población del estudio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To detect antibodies against CYP17, p53,VEGF, PDGF, TGF-alfa, FGF, FGFR2, IGF, IGFB, and CAIX.
    - To measure sex hormones in the samples
    - Single Nucleotide Polymorphisms analysis looking for predictors of response and toxicity
    - Detectar la presencia de anticuerpos frente a CYP17, p53, VEGF, PDGF, TGF-alfa, FGF, FGFR2, IGF, IGFB y CAIX
    - Medir las hormonas sexuales en las muestras
    - Análisis de los polimorfismos de nucleótido simple, en busca de factores pronósticos de respuesta y toxicidad
    E.3Principal inclusion criteria
    - Voluntary written informed consent.
    - Patients, even if surgically sterilized who:
    - Agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or
    - Agree to completely abstain from intercourse.
    - Patients 18 years or older.
    - Screening clinical laboratory values as specified below:
    - Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be <=2.5 X ULN.
    - Total bilirubin <=1.5 X ULN.
    - Estimated creatinine clearance using the Cockcroft-Gault formula must be >40 mL/minute.
    - Absolute neutrophil count (ANC) >=1500/mcL and platelet count >=100,000/mcL.
    - Histologically confirmed granulosa cell ovarian tumor with locally advanced non-resectable or metastasic disease, meseaurable or evaluable by RECIST.
    - Availability of sufficient biopsy material to confirm the malignant diagnosis of granulosa cell ovarian tumor by a centralized pathologist and to perform the determine the FOXL2 402C mutation ? G (C134W). However study entry will be allowed based just on the histological local diagnosis.
    - Life expectancy >=12 weeks
    - ECOG PS ≤ 2
    - Ejection fraction greater or equal to the value established as normal for each center by nuclear ventriculography (VRN) or echocardiogram (ECHO).
    - Stability of any concurrent chronic disease (defined as absence of acute exacerbations), serious infections, or major surgery within 4 weeks before first dose of study drug/randomization.
    - Consentimiento informado por escrito.
    - Pacientes que, aunque estén esterilizadas quirúrgicamente:
    - Estén de acuerdo en utilizar un método anticonceptivo de barrera eficaz durante todo el período de tratamiento del estudio y durante 4 meses después de la última dosis del fármaco del estudio, o
    - Acepten abstenerse completamente de mantener relaciones sexuales.
    - Pacientes de 18 años en adelante
    - Pacientes que hayan obtenido los siguientes resultados en los análisis clínicos realizados durante la selección:
    - Los niveles séricos de alanina-aminotransferasa (ALT) y aspartato-aminotransferasa (AST) debe ser <=2,5 X LSN.
    - Bilirrubina total <=1,5 X LSN.
    - El aclaramiento de creatinina estimado con la fórmula de Cockcroft-Gault debe ser >40 ml/minuto.
    - Recuento absoluto de neutrófilos (RAN) >=1500/mcl y recuento de plaquetas >=100 000/mcl.
    - Tumor ovárico de células de la granulosa confirmado histológicamente, metastásico o localmente avanzado irresecable, medible o evaluable según los criterios RECIST.
    - Disponibilidad de material de biopsia suficiente para que un anatomopatólogo confirme en el laboratorio central el diagnóstico del cáncer de ovario de células de la granulosa y para determinar en el gen FOXL2 la presencia de la mutación 402C ? G (C134W). No obstante, no se permitirá la inclusión en el estudio a partir únicamente del diagnóstico histológico local.
    - Esperanza de vida >=12 semanas
    - ECOG PS ≤ 2
    - Fracción de eyección determinada mediante ventriculografía nuclear (VRN) o ecocardiograma (ECO) que sea mayor o igual al valor establecido como normal en cada centro.
    - Estabilidad de cualquier enfermedad crónica concurrente (entendida como ausencia de exacerbaciones agudas), infecciones graves o cirugía mayor en las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    - History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 4.02)(56), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
    - New York Heart Association Class III or IV heart failure.
    - ECG abnormalities of:
    - Q-wave infarction, unless identified 6 or more months prior to screening
    - QTc interval > 460 msec
    - Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
    - Patient has received other investigational drugs within 28 days before enrollment
    - Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy.
    - Prior therapy with orteronel, ketoconazole, abiraterone, aminoglutethimide or enzalutamide.
    - Patients received radical radiotherapy < 4 weeks before starting the study treatment or who have not recovered from the toxicities of radiotherapy. Palliative radiotherapy of painful bone lesions is allowed up to 14 days before the start of study treatment.
    - Known hypersensitivity to compounds related to orteronel (abiraterone, galaterone, ketoconazole) or to orteronel excipients (mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium aluminometasilicate, magnesium stearate, hypromellose 2910, polyethylene glycol, titanium dioxide, ferric oxide).
    - Uncontrolled hypertension despite appropriate medical therapy (BP of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit). Note: patients may be rescreened after adjustment of antihypertensive medications.
    - Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator?s opinion, potentially interfere with participation in this study.
    - Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
    - Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel, including difficulty swallowing tablets.
    - Antecedentes de infarto de miocardio, cardiopatía isquémica sintomática inestable, arritmias de grado > 2 (criterios CTCAE del NCI, versión 4.02)(56) en la actualidad, acontecimientos tromboembólicos (p. ej., trombosis venosa profunda, embolia pulmonar o acontecimientos cerebrovasculares sintomáticos), o cualquier otra afección cardiaca (p. ej., miocardiopatía restrictiva con derrame pericárdico) en los 6 meses previos a la primera dosis del fármaco del estudio. Se permite fibrilación auricular crónica estable en tratamiento estable con anticoagulantes.
    - Insuficiencia cardíaca de clase III o IV según la New York Heart Association.
    - Anomalías en el ECG de:
    - Infarto con onda Q, salvo que se identifique 6 o más meses antes de la selección
    - Intervalo QTc > 460 ms
    - Pacientes embarazadas o en periodo de lactancia. La confirmación de que la paciente no está embarazada deberá establecerse mediante una prueba de embarazo en suero negativa ?(gonadotropina coriónica humana [?-hCG]) realizada durante la selección. La prueba de embarazo no será necesaria en el caso de mujeres posmenopáusicas ni en las esterilizadas por métodos quirúrgicos.
    - Pacientes que haya recibido otro fármaco experimental en los 28 días previos a su inclusión en el estudio
    - Diagnóstico o tratamiento de otra neoplasia maligna en los 2 años anteriores a la inclusión en el estudio, a excepción de la resección completa de un carcinoma basocelular o epidermoide cutáneo o una neoplasia maligna in situ.
    - Tratamiento previo con orteronel, ketoconazol, abiraterona, aminoglutetimida o enzalutamida.
    - Pacientes que hayan recibido radioterapia radical < 4 semanas antes de iniciar el tratamiento del estudio o que no se hayan recuperado de las toxicidades de la radioterapia. Se permite la administración de radioterapia paliativa de lesiones óseas dolorosas hasta 14 días antes del inicio del tratamiento del estudio.
    - Hipersensibilidad conocida a compuestos relacionados con orteronel (abiraterona, galaterona, ketoconazol) o con los excipientes de orteronel (manitol, celulosa microcristalina, hidroxipropilcelulosa, aluminosilicato de magnesio, glicolato sódico de almidón, estearato de magnesio, hipromelosa 2190, polietilenglicol, dióxido de titanio, óxido férrico)”.
    - Hipertensión no controlada a pesar de un tratamiento farmacológico adecuado (presión arterial mayor de 160 mm Hg (sistólica) y 90 mm Hg (diastólica) en 2 determinaciones independientes realizadas en un intervalo de tiempo no superior a 60 minutos durante la visita de selección). Atención: es posible volver a realizar a las pacientes los exámenes de selección para su posible inclusión en el estudio una vez corregida la hipertensión con fármacos antihipertensores.
    - Hepatitis B o C crónica activa conocida, enfermedad que suponga un peligro para la vida y que no esté relacionada con el cáncer o cualquier trastorno médico o psiquiátrico grave que, a juicio del investigador, podría interferir en la participación en este estudio.
    - Incapacidad probable para cumplir con el protocolo o colaborar completamente con el investigador y el personal del centro.
    - Antecedentes conocidos de enfermedad gastrointestinal (GI) o procedimiento GI que pudiera interferir en la absorción o la tolerabilidad de GI orteronel, incluida la dificultad para tragar los comprimidos.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical benefit is defined as the average of patients with radiological response (partial or complete) plus stable disease longer than 6 months by RECIST 1.1 criteria
    El beneficio clínico se define como el promedio de pacientes con respuesta radiológica (parcial o completa) más enfermedad estable durante más de 6 meses según los criterios RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks
    Cada 8 semanas
    E.5.2Secondary end point(s)
    - Overall Response Rate according to RECIST 1.1 criteria.
    - Progression free survival.
    - Overall Survival.
    - Reduction of sex hormones production (serum testosterone, DHEA-S, androstenedione, progesterone and estradiol).
    - Tasa de respuesta global según los criterios RECIST 1.1.
    - Supervivencia libre de progresión
    - Supervivencia global.
    - Reducción de la concentración de las hormonas sexuales (testosterona sérica, DHEA-S, androstendiona, progesterona y estradiol).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Every 8 weeks
    - Every 8 weeks
    - Every 12 weeks
    - Every 8 weeks
    - Cada 8 semanas
    - Cada 8 semanas
    - Cada 12 semanas
    - Cada 8 semanas
    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 No
    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.8.3 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
    LVLS
    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 days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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