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    EudraCT Number:2017-003183-13
    Sponsor's Protocol Code Number:OLATRA
    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:2018-04-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003183-13
    A.3Full title of the trial
    Phase-II study of olaparib as maintenance therapy after response to trabectedinpegylated liposomal doxorubicin in recurrent ovarian carcinoma.
    Ensayo fase II de Olaparib de mantenimiento tras la respuesta a trabectedina y doxorrubicina liposomal pegilada en cáncer de ovario recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib treatment in patients with ovarian cancer.
    Tratamiento con Olaparib en pacientes con cáncer de ovario.
    A.4.1Sponsor's protocol code numberOLATRA
    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 SponsorGEICO - Grupo Español de Investigación en Cáncer de Ovario
    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 supportAstrazeneca
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES
    B.5.2Functional name of contact pointAna María Moreno
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Antonio Lopez 16 1A
    B.5.3.2Town/ cityPinto/Madrid
    B.5.3.3Post code28320
    B.5.4Telephone number0034918166804
    B.5.5Fax number0034918169172
    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. name Lynparza
    D. of the Marketing Authorisation holderAztraZeneca AB
    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, hard
    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 INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeOLAPARIB
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Ovarian Carcinoma
    Cáncer de ovario
    E.1.1.1Medical condition in easily understood language
    Ovarian Carcinoma
    Cáncer de ovario
    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 LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Effect of maintenance treatment with olaparib on progression free survival (PFS) in patients with recurrent ovarian carcinoma, treatment-free interval of platinum (TFIp) higher than 6 months, and BRCA1/2 germline or somatic deleterious mutation, who have received treatment with trabectedin + pegylated liposomal doxorubicin (PLD) and reached a partial or complete response, assessed by RECIST 1.1 criteria.
    Efecto del tratamiento de mantenimiento con olaparib sobre la supervivencia libre de progresión (SLP) en pacientes con carcinoma de ovario recurrente, intervalo libre de platinos (ILP) superior a seis meses y mutación nociva de línea germinal o somática en BRCA1/2, que han recibido tratamiento con trabectedina y doxorubicina liposomal pegilada (PLD) y obtuvieron una respuesta parcial o completa, evaluada mediante criterios RECIST 1.1.
    E.2.2Secondary objectives of the trial
    - Effect of maintenance treatment with olaparib on Time to First Subsequent Treatment (TFST).
    - Effect of maintenance treatment with olaparib on Time to Second Subsequent Treatment (TSST).
    - Effect of maintenance treatment with olaparib on PFS2.
    - Safety and tolerability of maintenance treatment with olaparib.
    - Evaluate predictive biomarkers of long PFS with olaparib and molecular response.
    • Efecto del tratamiento de mantenimiento con olaparib sobre el tiempo hasta el primer tratamiento posterior (TPTP).
    • Efecto del tratamiento de mantenimiento con olaparib sobre el tiempo hasta el segundo tratamiento posterior (TSTP).
    • Efecto del tratamiento de mantenimiento con olaparib sobre la SLP2.
    • Seguridad y tolerabilidad del tratamiento de mantenimiento con olaparib.
    • Evaluar los biomarcadores predictivos de una SLP larga con olaparib y respuesta molecular.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures.
    2. Female aged ≥18 years.
    3. Patients with high-grade serous or endometrioid ovarian carcinoma.
    4. Treatment-free interval of last platinum (TFIp) higher than 6 months.
    5. BRCA1/2 germline or somatic deleterious mutation.
    6. Patient must have received two or more previous chemotherapy (CT) regimens, including first line platinum based CT and last trabectedin + PLD. There is no limit of previous number of CT lines.
    7. Last CT prior to the inclusion in the trial must be trabectedin + PLD. Patients must have received at least 4 cycles of treatment, and have reached a partial or complete response, assessed by RECIST 1.1 criteria and no evidence of a rising CA 125, following the chemotherapy course.
    8. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
    - Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    - Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase
    (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
    - Patients must have creatinine clearance estimated using the Cockcroft-Gault
    equation of ≥51 mL/min: Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72 a where F=0.85 for females.
    9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    10. Life expectancy ≥ 16 weeks.
    11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
    - Amenorrheic for 1 year or more following cessation of exogenous hormonal
    - Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the
    post menopausal range for women under 50
    - Radiation-induced oophorectomy with last menses >1 year ago
    - Chemotherapy-induced menopause with >1 year interval since last menses
    - Surgical sterilisation (bilateral oophorectomy or hysterectomy)
    12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
    13. Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer must be available for central testing if sBRCA analysis is not available at study site. If there is not written confirmation of the availability of an archived tumour sample or gBRCA test performed prior to enrolment the patient is not eligible for the study. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfil the following criteria:
    - Provision of informed consent for genetic research.
    - Provision of informed consent for biomarker research.
    1. Haber otorgado su consentimiento antes de cualquier procedimiento específico del estudio.
    2. Edad ≥18 años.
    3. Pacientes con carcinoma de ovario endometrioide o seroso de gran malignidad.
    4. Intervalo libre desde el último platino (ILP) superior a seis meses.
    5. Mutación nociva de línea germinal o somática en BRCA1/2.
    6. La paciente debe haber recibido dos o más programas de quimioterapia (QT), incluidas la QT de primera línea con derivados de platino y la última con trabectedina y PLD. No existe límite en cuanto al número de líneas de QT anteriores.
    7. La última QT anterior a la inclusión en el ensayo debe ser con trabectedina y PLD. Las pacientes deben haber recibido como mínimo cuatro ciclos de tratamiento y haber obtenido una respuesta parcial o completa, evaluada mediante criterios RECIST 1.1, y ningún indicio de aumento del nivel de CA 125 tras el curso de la quimioterapia.
    8. Las pacientes deben tener una función normal de los órganos y la médula ósea medida en los 28 días anteriores a la administración del tratamiento del estudio, tal y como se define a continuación:
    − Hemoglobina ≥ 10,0 g/dl sin ninguna transfusión sanguínea en los 28 días anteriores
    − Recuento absoluto de neutrófilos (ANC) ≥ 1,5 x 109/l
    − Recuento de plaquetas ≥ 100 x 109/L
    − Bilirrubina total ≤ 1,5 x límite superior normal (ULN) oficial
    − Aspartato aminotransferasa (AST) (transaminasa glutamicoexaloacética sérica [SGOT])/alanina aminotransferasa (ALT) (transaminasa glutámico-pirúvica sérica [SGPT]) ≤ 2,5 x límite superior normal , salvo que haya metástasis hepáticas, en cuyo caso, debe ser ≤ 5x ULN
    − Las pacientes deben tener un aclaramiento de creatinina calculado mediante la ecuación de Cockcroft-Gault ≥51 ml/min.
    9. Eastern Cooperative Oncology Group (ECOG) 0-1.
    10. Esperanza de vida ≥ 16 semanas.
    11. Estado posmenopáusico o de ausencia de embarazo en mujeres con capacidad de concebir: prueba de embarazo en orina o suero con resultado negativo en los 28 días de tratamiento del estudio y confirmada antes del primer día del tratamiento.
    El estado posmenopáusico se define como:
    − Mujeres amenorreicas durante un año o más tras el cese de tratamientos hormonales exógenos
    − Niveles de lutropina (LH) y folitropina (FSH) en el intervalo posmenopáusico de mujeres de menos de 50 años
    − Ovariectomía provocada por radiación con las últimas menstruaciones >1 año antes
    − Menopausia provocada por quimioterapia con un intervalo de >1 año desde las últimas menstruaciones
    − Esterilización quirúrgica (ovariectomía bilateral o histerectomía)
    12. La paciente puede y está dispuesta a cumplir el protocolo durante el estudio, lo que incluye someterse al tratamiento y las consultas y los reconocimientos programados.
    13. Deberá disponerse de una muestra neoplásica fijada en formol e incluida en parafina (FFPE) del cáncer primario para las pruebas del centro si no hay disponible un análisis sBRCA en el centro del estudio. Si no existe confirmación por escrito de la disponibilidad de una muestra neoplásica o una prueba gBRCA realizada antes de la inscripción en archivo, la paciente no es apta para el estudio.
    Para su inclusión en i) la investigación genética exploratoria opcional y ii) la investigación opcional de biomarcadores, las pacientes han de cumplir los siguientes criterios:
    − Otorgamiento del consentimiento informado para la investigación genética
    − Otorgamiento del consentimiento informado para la investigación de biomarcadores
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to both sponsor staff
    and/or staff at the study site).
    2. Any previous treatment with PARP inhibitor.
    3. Rising CA125 after chemotherapy is finished until inclusion. Pre-treatment CA-125 measurements must meet criterion specified below:
    - If the first value is within upper limit of normal (ULN) the patient is eligible to
    be randomised and a second sample is not required.
    - If the first value is greater than ULN a second assessment must be performed at least 7 days after the first. If the second assessment is ≥ 15% more than the first, the patient is not eligible.
    4. Other malignancy within the last 3 years except: adequately treated non-melanoma
    skin cancer, curatively treated cervical carcinoma in situ, breast carcinoma in situ,
    and grade 1 endometrial carcinoma in stage 1.
    5. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period
    or family history of long QT syndrome.
    6. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin,
    clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,
    saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg.
    ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required
    washout period prior to starting olaparib is 2 weeks.
    7. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
    8. Persistent toxicities (> Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
    9. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of these diseases.
    10. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
    11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
    12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    13. Patients considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
    14. Patients unable to swallow orally administered medication and patients with
    gastrointestinal disorders likely to interfere with absorption of the study medication.
    1. Participación en la planificación o realización del estudio (se aplica tanto al personal del promotor como al personal del centro del estudio).
    2. Algún tratamiento anterior con un inhibidor de PARP.
    3. Aumento de CA 125 tras la finalización de la quimioterapia hasta la inclusión. Las mediciones de CA 125 anteriores al tratamiento deben cumplir el criterio especificado a continuación:
    - Si el primer valor se encuentra por debajo del límite superior normal (LSN), la paciente es apta para su inclusión aleatorizada y no se requiere una segunda muestra.
    - Si el primer valor es superior al LSN, es preciso realizar una segunda evaluación como mínimo siete días después de la primera. Si la segunda evaluación supera a la primera en ≥ 15 %, la paciente no es apta.
    4. Otro tumor maligno en los últimos tres años, excepto: cáncer de piel (no melanoma) tratado adecuadamente, carcinoma cervicouterino localizado, carcinoma de mama localizado y carcinoma de endometrio de grado 1 en etapa 1.
    5. Electrocardiograma (ECG) en reposo con intervalo QT corregido (QTc) > 470 ms en dos o más ocasiones en un periodo de 24 horas o antecedentes familiares de síndrome de QT largo.
    6. Tratamiento concomitante con fármacos conocidos como inhibidores potentes de la CYP3A (por ejemplo, itraconazol, telitromicina, claritromicina, inhibidores de la proteasa potenciados con ritonavir o cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) o inhibidores moderados de la CYP3A (por ejemplo, ciprofloxacino, eritromicina, diltiazem, fluconazol, verapamilo). Antes de comenzar el tratamiento con olaparib, se requiere un periodo de lavado de dos semanas.
    7. Tratamiento concomitante con fármacos conocidos como inductores potentes de la CYP3A (por ejemplo, fenobarbital, enzalutamida, fenitoína, rifampicina, rifabutina, rifapentina, carbamazepina, nevirapina e hipérico) o moderados (por ejemplo, bosentán, efavirenz, modafinilo). Antes de comenzar el tratamiento con olaparib, se requiere un periodo de lavado de cinco semanas para la enzalutamida o el fenobarbital y de tres semanas para otros agentes.
    8. Efectos tóxicos persistentes (> grado 2 de los CTCAE [Common Terminology Criteria for Adverse Event]) debidos a un tratamiento antineoplásico previo, excluida la alopecia.
    9. Pacientes que presentan síndrome mielodisplásico/leucemia mieloide aguda o signos indicativos de estas enfermedades.
    10. Pacientes con metástasis cerebrales sintomáticas no controladas. No se precisa una gammagrafía para confirmar la ausencia de metástasis cerebrales. La paciente podrá recibir una dosis estable de corticosteroides antes y durante el estudio, siempre que su administración haya comenzado como mínimo cuatro semanas antes del tratamiento.
    11. Pacientes con compresión medular, salvo que se considere que han recibido tratamiento definitivo para ello y mantengan indicios de enfermedad clínicamente estable durante 28 días.
    12. Cirugía mayor en las dos semanas anteriores al inicio del tratamiento del estudio, en cuyo caso, las pacientes deben haberse recuperado de los efectos de la intervención.
    13. Pacientes consideradas de alto riesgo médico debido a un trastorno médico grave no controlado, enfermedad sistémica no maligna o infección activa no controlada. Entre otros ejemplos, pueden citarse los siguientes: arritmia ventricular no controlada, infarto de miocardio reciente (en los tres meses anteriores), trastorno convulsivo importante no controlado, compresión de la médula espinal inestable, síndrome de la vena cava superior, neumopatía intersticial bilateral extensa en TAC de alta resolución (HRCT) o trastorno psiquiátrico que impida la obtención del consentimiento informado.
    14. Pacientes que no puedan tragarse los medicamentos administrados por vía oral y pacientes con trastornos digestivos que probablemente interfieran con la absorción de los medicamentos del estudio.
    15. Mujeres lactantes.
    16. Pacientes con un sistema inmunológico débil, por ejemplo, pacientes que se sabe que son seropositivas al virus de inmunodeficiencia humana (VIH).
    17. Paciente con hipersensibilidad conocida al olaparib o a cualquiera de los excipientes del producto.
    18. Paciente con hepatitis activa conocida (es decir, hepatitis B o C).
    19. Trasplante alogénico de médula ósea o doble trasplante de sangre de cordón umbilical (dUCBT) anteriores.
    20. Transfusiones de sangre entera en los 120 días anteriores al ingreso en el estudio (las transfusiones de concentrado de eritrocitos y plaquetas son aceptables).
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    Supervivencia Libre de Progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks
    Cada 12 semanas
    E.5.2Secondary end point(s)
    - Time to First Subsequent Treatment (TFST)
    - Time to Second Subsequent Treatment (TSST)
    - PFS2
    - Number of Adverse Events
    - Predictive biomarkers of long PFS with olaparib and molecular response.
    - TPTP: período comprendido entre la fecha de la primera dosis de olaparib (inicio del tratamiento) y la fecha del comienzo de primer tratamiento posterior o la muerte por cualquier causa si se produce antes del comienzo del primer tratamiento posterior.
    - TSTP: período comprendido entre la fecha de la primera dosis de olaparib (inicio del tratamiento) y la fecha del comienzo de segundo tratamiento posterior o la muerte por cualquier causa si se produce antes del comienzo del segundo tratamiento posterior.
    - SLP2: intervalo comprendido entre la primera dosis de olaparib (inicio del tratamiento) y el primero de los eventos de progresión posteriores a ella que se use con la variable principal SLP, o la muerte.
    - Número de Acontecimientos Adversos
    - Biomarcadores predictivos de una SLP larga con olaparib y respuesta molecular.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Time to First Subsequent Treatment (TFST): every 4 weeks
    - Time to Second Subsequent Treatment (TSST): Every 4 weeks
    - PFS2: Every 12 weeks
    - Safety and tolerability will be evaluated in a onging basis during the treatment.
    - At the end of the study
    - TPTP: cada 4 semanas
    - TSTP: cada 4 semanas
    - SLP2: cada 12 semanas
    - Seguridad y Tolerabilidad será evaluada de forma continua durante el tratamiento
    - A la finalización del estudio
    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. 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.8.3 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 concerned15
    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
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    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 Decision2018-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-07-27
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