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    Summary
    EudraCT Number:2012-001948-21
    Sponsor's Protocol Code Number:GETHI-2011-03
    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:2012-05-29
    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 number2012-001948-21
    A.3Full title of the trial
    Open Phase II Study of Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary. GreKo Study.
    Estudio fase II abierto de ketoconazol como inhibidor de la enzima CYP17 en cáncer de la granulosa ovárica localmente avanzado o diseminado. Estudio GreKo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ketoconazole in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary.
    Estudio de ketoconazol en cáncer de la granulosa ovárica localmente avanzado o diseminado.
    A.3.2Name or abbreviated title of the trial where available
    GreKo
    A.4.1Sponsor's protocol code numberGETHI-2011-03
    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
    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 supportMinistry of Health
    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 AddressC/ Salamanca, 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 Yes
    D.2.1.1.1Trade name FUNGAREST
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG, S.A.
    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 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.3.9.1CAS number 65277-42-1
    D.3.9.3Other descriptive nameKETOCONAZOLE
    D.3.9.4EV Substance CodeSUB08373MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary
    Cáncer de la granulosa ovárica localmente avanzado o diseminado
    E.1.1.1Medical condition in easily understood language
    Granulosa Cell Tumour of Ovary
    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 14.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of ketoconazole in terms of overall response rate in the treatment of metastatic or locally advanced unresectable granulosa cell tumour of ovary.
    Evaluar la eficacia de ketoconazol en términos de tasa de respuesta global en el tratamiento de carcinoma de la granulosa ovárica metastásico o localmente avanzado no resecable.
    E.2.2Secondary objectives of the trial
    - Determine the safety profile of ketoconazole in this group of patients.
    - Determine the time to progression (PFS) measured by an external evaluator.
    - Determine overall survival (OS).
    - Determine the quality of life.
    - Determine the response rate and PFS measured by local investigators.
    - Determinar el perfil de seguridad de ketoconazol en este grupo de pacientes.
    - Determinar el tiempo hasta progresión (PFS, por sus siglas en inglés) medido por un evaluador externo.
    - Determinar la supervivencia global (OS, por sus siglas en inglés).
    - Determinar la calidad de vida.
    - Determinar el porcentaje de respuestas y la PFS medidos por los investigadores locales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients obtained their written informed consent.
    - Women >= 18 years old.
    - ECOG <= 1.
    - Histologically confirmed carcinoma of granulosa cell in ovary.
    - Availability of sufficient biopsy material to confirm the diagnosis by a centralized pathologist and determination of the FOXL2 402C mutation - G (C134W).
    - Metastatic or unresectable disease.
    - Imaging measurable disease.
    - Life expectancy >= 12 weeks.
    - Patients with adequate hepatic function, defined by:
    * Serum values of AST and ALT <= 3 x UNL (except in the presence of metastases then allowed values <= 5 x UNL)
    * Total bilirubin <= 1.5 x UNL
    - Patients with adequate bone marrow function, defined by:
    * Absolute neutrophil count >= 1.5 x 10*9 / L
    * Platelets >= 100 x 10*9 / L
    * Hb > 9 g / dL
    - Patients with adequate renal function: serum creatinine <= 1.5 x UNL.
    - Absence of any impediment to comply with the study protocol.
    - Women of childbearing potential, sexually active, not under hysterectomy or bilateral adnexectomy, should follow the following guidelines on contraception:
    - Negative serum or urine pregnancy test within 72 hours before the start of treatment.
    - Use of a medically accepted contraceptive method during: the 2 months prior to study treatment, during the study and 3 months after the last dose of study treatment.
    - Pacientes que hayan otorgado su consentimiento informado por escrito
    - Mujeres con edad igual o superior a 18 años
    - ECOG <=1
    - Diagnóstico de carcinoma de la granulosa ovárica confirmado histológicamente
    - Disponibilidad de material de biopsia suficiente para la confirmación del diagnóstico por un patólogo centralizado y determinación de la mutación FOXL2 402C-G (C134W).
    - Enfermedad metastásica o no resecable
    - Enfermedad medible radiológicamente
    - Esperanza de vida >= 12 semanas.
    - 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
    - Pacientes con adecuada función de la médula ósea, definida por:
    * Recuento absoluto de neutrófilos >= 1,5 x 10*9/L,
    * Plaquetas >= 100 x 10*9/L,
    * Hb >9 g/dL.
    - Pacientes con función renal adecuada: creatinina sérica <= 1,5 x LSN
    - Ausencia de cualquier impedimento para el cumplimiento del protocolo del estudio
    - Las mujeres en edad fértil sexualmente activas, no sometidas a histerectomía o doble anexectomía, deben seguir las indicaciones sobre contracepción siguientes:
    - 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, 3 meses después de la última dosis del tratamiento
    E.4Principal exclusion criteria
    - Patients with another primary tumor 2 years before starting the study drug, with the exception of cervical carcinoma in situ or adequately treated or removed completely or basalioma or superficial bladder carcinoma.
    - 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.
    - Patients with heart failure or clinically significant heart disease, including any of the following:
    * History or presence of uncontrolled severe ventricular arrhythmia.
    * Clinically significant bradycardia at rest.
    * LVEF <45% assessed by 2-D echocardiogram (ECHO) or MUGA. However, these tests are not mandatory per protocol.
    - Any of the following diseases within 6 months prior to the start of study drug: Myocardial infarction (MI), severe or unstable angina, coronary revascularization, congestive heart failure (CHF), stroke (CVA), transient ischemic attack (TIA).
    - Patients with gastrointestinal function failure or gastric disease that significantly alter the ketoconazole absorption, for example, severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption, extensive resection (> 1m) of the small intestine or inability to swallow oral medication.
    - Diagnosis of infection with human immunodeficiency virus (HIV).
    - Pregnant women or nursing.
    - Women of childbearing potential not using effective contraceptive method.
    - Patients who are unwilling or unable to comply with the protocol.
    - 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.
    - 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.
    - 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.
    * FEVI <45% evaluada por ecocardiograma 2-D (ECO) o MUGA. Sin embargo, estas pruebas no son obligatorias por protocolo.
    - 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), ataque isquémico transitorio (TIA)
    - Pacientes con fallo en la función gastrointestinal o con enfermedad gástrica que altera significativamente la absorción de ketoconazol, como por ejemplo: enfermedades ulcerosas graves, nauseas descontroladas, vómitos, diarrea, síndrome de mala absorción, resección extensa (>1m) del intestino delgado o incapacidad para tragar medicación oral.
    - Diagnóstico de infección por el virus de la inmunodeficiencia humana (VIH).
    - Mujeres embarazadas o en lactancia.
    - Mujeres en edad fértil que no empleen un método anticonceptivo efectivo.
    - Pacientes que no quieran o no puedan cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate
    Tasa de respuesta
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks
    Cada 8 semanaas
    E.5.2Secondary end point(s)
    - Clinical benefit.
    - Progression-free survival.
    - Overall survival.
    - Overall response rate.
    - Quality of life (validated in Spanish EORTC QLQ-C30 questionnaire).
    - Safety profile.
    - Beneficio clínico.
    - Supervivencia libre de progresión.
    - Supervivencia global.
    - Respuesta global.
    - Calidad de vida (cuestionario EORTC QLQ-C30).
    - Perfil de seguridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Every 4 weeks.
    - Every 8 weeks.
    - Until death.
    - Every 8 weeks.
    - Every 4 weeks.
    - Every 4 weeks.
    - Cada 4 semanas.
    - Cada 8 semanas.
    - Hasta fallecimiento.
    - Cada 8 semanas.
    - Cada 4 semanas.
    - Cada 4 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 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 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 concerned10
    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
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 12
    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 state17
    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)
    the expected normal treatment of that condition
    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 Decision2012-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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