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    Summary
    EudraCT Number:2014-004020-21
    Sponsor's Protocol Code Number:PR-Trab-PT
    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:2015-01-26
    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 number2014-004020-21
    A.3Full title of the trial
    Reintroduction of platinum-based therapy after treatment with trabectedin in patients with relapsed ovarian cancer resistant to platinum
    Reintroducción de tratamiento basado en platino después del tratamiento con trabectedina en pacientes en recaída de cáncer de ovario resistentes a platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reintroduction of platinum-based therapy after treatment with trabectedin in patients with relapsed ovarian cancer resistant to platinum
    Reintroducción de tratamiento basado en platino después del tratamiento con trabectedina en pacientes en recaída de cáncer de ovario resistentes a platino
    A.4.1Sponsor's protocol code numberPR-Trab-PT
    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 SponsorFundación para la investigación biomédica del Hospital Clínico San Carlos
    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 supportFundación para la investigación biomédica del Hospital Clínico San Carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUICEC
    B.5.2Functional name of contact pointana belen rivas paterna
    B.5.3 Address:
    B.5.3.1Street Addressprofesor martin lagos s/n
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number00349133030002774
    B.5.5Fax number0034913303515
    B.5.6E-mailfibucicec.hcsc@saldud.madrid.org
    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 Yondelis 0,25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar, 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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeTRABECTEDIN
    D.3.9.3Other descriptive nameTRABECTEDIN
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    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.IMP: 2
    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 Carboplatin
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUB06614MIG
    D.3.9.1CAS number SUB06614MIG
    D.3.9.2Current sponsor codeCARBOPLATIN
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 7
    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.IMP: 3
    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 DEXAMETHASONE
    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
    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 INNDEXAMETHASONE
    D.3.9.2Current sponsor codeDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Ovarian cancer resistant to the treatment with platinum
    Cáncer de ovario resistente a platinos
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer resistant to the treatment with platinum
    Cáncer de ovario resistente al tratmiento con platino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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
    Objective response rate and time to pathology progression (assessed according to RECIST 1.1)
    Tasa de respuesta objetiva y tiempo a la progresión de enfermedad (evaluadas según criterios RECIST 1.1)
    E.2.2Secondary objectives of the trial
    Time to progression of the 4th / 5th line treatment (platinum regimen subsequent to treatment with trabectedin) compared to the time to progression of the 2nd / 3rd line (regime prior to inclusion in the study platinum) (TTP Pt2 / TTP Pt1). To be considered positive, the result must be ?1.
    Time to progression with the treatment of trabectedin versus Pt2 TTP / TTP ratio Pt1
    Time to progression with the treatment of trabectedin versus TTP Pt.2
    Duration of response to treatment with trabectedin.
    To assess whether progression-free survival with trabectedin added to the progression-free survival of subsequent platinum makes the platinum-free interval greater than 6 months
    Serological response of CA-125 according to the criteria of GCIG
    Assessing the quality of life of patients during treatment with trabectedin by QLQ-C30 questionnaire and the specific module QLQ-OV28 ovarian cancer.
    To assess the safety profile of trabectedin
    Tiempo a la progresión de la 4ª/5ª línea de tratamiento comparado con el tiempo a la progresión de la 2ª/3ª línea (régimen de platino previo a la inclusión en el estudio) TTP Pt2/ TTP Pt1 ?1.
    Tiempo a la progresión con el tratamiento de trabectedina versus la relación TTP Pt2/ TTP Pt1
    Tiempo a la progresión con el tratamiento de trabectedina versus TTP Pt 2
    Duración de la respuesta al tratamiento con trabectedina.
    Evaluar si la progresión libre de enfermedad con trabectedina añadida a la progresión libre de enfermedad del platino subsiguiente consigue que el intervalo libre de platino sea superior a 6 meses
    Respuesta serológica de CA-125 de acuerdo a los criterios del GCIG
    Evaluar la calidad de vida de los pacientes durante el tratamiento con trabectedina mediante el cuestionario QLQ-C30 y el módulo específico para cáncer de ovario QLQ-OV28.
    Evaluar el perfil de seguridad de trabectedina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological diagnosis of epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma.
    2. Pretreatment with carboplatin + paclitaxel, carboplatin or gemcitabine + carboplatin + liposomal doxorubicin.
    3. Resistance to treatment with platinum.
    4. Two or three lines of previous chemotherapy.
    6. ECOG PS 0-1
    7. Adequate bone marrow function:
    8. Creatinine clearance ? 30 ml / min, serum creatinine ? 1.5 mg / dL (? 132.6 mmol / l). Creatine phosphokinase (CPK) ? 2.5 x ULN
    10. Adequate hepatic function.
    11. Negative pregnancy test within 7 days prior to initiation of treatment.
    12. Women age: for the use of effective contraception during treatment and for 3 months thereafter.
    13. Informed consent of the patient.
    1. Diagnóstico histológico o citológico de carcinoma epitelial de ovario, trompa de Falopio o carcinoma peritoneal primario.
    2. Pacientes que hayan recibido tratamiento previo con carboplatino + paclitaxel, carboplatino + gemcitabina o carboplatino + doxorubicina liposomal (segunda o tercera líneas). Las pacientes pueden haber recibido terapia antiangiogénica como bevacizumab, pazopanib, AMG 386 (trebananib) o nintedanib.
    3. Pacientes resistentes al tratamiento con platinos, definido como recaída entre las cuatro semanas de finalizar el tratamiento con platinos y menos de 6 meses desde el último tratamiento quimioterápico basado en platinos.
    4. Dos o tres líneas de quimioterapia previas.
    5. Los pacientes serán elegibles si tienen:
    a. Enfermedad no medible
    b. Enfermedad evaluable por TAC o MRI de acuerdo a los criterios RECIST 1.1 o
    c. Incremento de CA125 de acuerdo a las guías del GCIC, en caso de enfermedad no medible por RECIST 1.1 (como ascitis o engrosamiento del peritoneo). El CA-125, medido en dos ocasiones, separadas al menos una semana, debe ser:
    i. superior a dos veces el valor normal en pacientes cuyo CA-125 estaba por debajo del valor normal durante el tratamiento previo, o
    ii. superior a dos veces el valor del nadir alcanzado durante el tratamiento previo en pacientes cuyo CA-125 no se normalizó durante el tratamiento previo
    6. ECOG PS 0 - 1
    7. Adecuada función medular:
    - Hemoglobina ? 9 g/dl
    - Recuento absoluto de neutrófilos (RAN) ? 1.500/mm3
    - Recuento de plaquetas ? 100.000/mm3
    8. Aclaramiento de creatinina ? 30 ml/min, creatinina sérica ? 1,5 mg/dl (? 132,6 ?mol/l)
    9. Creatina fosfoquinasa (CPK) ? 2,5 x LSN
    10. Adecuada función hepática.
    - Bilirrubina ? límite superior de la normalidad (LSN)
    - Fosfatasa alcalina ? 2,5 x LSN (si la elevación pudiera ser de origen óseo, se deben considerar las isoenzimas hepáticas 5-nucleotidasa o gamma glutamil transpeptidasa [GGT]).
    - Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ? 2,5 x LSN
    - Albúmina ? 25 g/l.
    11. Test de embarazo negativo en los 7 días previos al inicio del tratamiento.
    12. Las mujeres en edad fértil deben aceptar la utilización de un método anticonceptivo eficaz durante el tratamiento y hasta 3 meses después. Se consideran métodos adecuados los anticonceptivos administrados bajo prescripción médica (orales, inyectables o en parche), dispositivo intrauterino, método de doble barrera o esterilización de la pareja (no aplicable a las pacientes que hayan sido esterilizadas quirúrgicamente).
    13. Consentimiento informado de la paciente.
    E.4Principal exclusion criteria
    1. Have received more than three prior chemotherapy lines.
    2. Prior exposure to trabectedin or hypersensitivity to any of the excipients
    3. Any severe or uncontrolled as, for example, uncontrolled systemic infection requiring therapy condition.
    4. Other prior malignancy treated within 5 years prior to enrollment in the study, except nonmelanoma skin carcinoma completely resected or in situ of the cervix or the cervix or basal cell skin carcinoma treated with curative intent .
    5. Any uncontrolled serious pre-existing medical or psychiatric condition and / or that could interfere with subject's safety, provision of informed consent or comply with study procedures.
    6. Metastatic brain or leptomeningeal disease.
    7. Treatment with any investigational product within 30 days prior to study entry.
    8. Pregnant or lactatiom
    9. significant chronic liver disease such as cirrhosis or active hepatitis
    1. Haber recibido más de tres líneas de quimioterapia previas.
    2. Exposición previa a trabectedina o hipersensibilidad a alguno de sus excipientes
    3. Cualquier condición grave o no controlada como, por ejemplo, infección no controlada que requiere terapia sistémica.
    4. Otros tumores malignos previos tratados en los 5 años previos a su inclusión en el estudio, excepto carcinoma de piel no melanoma completamente resecado o carcinoma in situ de cérvix o del cuello del útero o carcinoma de células basales de la piel tratados con intención curativa.
    5. Cualquier condición médica o psiquiátrica preexistente grave y/o no controlada que pudiera interferir con la seguridad del sujeto, la prestación del consentimiento informado, o el cumplimiento de los procedimientos del estudio.
    6. Enfermedad metastásica cerebral o leptomeningea.
    7. Tratamiento con cualquier producto en investigación en los 30 días anteriores a la inclusión en el ensayo.
    8. Mujeres embarazadas o en periodo de lactancia
    9. Enfermedad hepática crónica significativa como cirrosis o hepatitis activa
    E.5 End points
    E.5.1Primary end point(s)
    Radiological assessment of patient response
    evaluación de la respuesta radiológica de los pacientes
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 9 and 18 weeks of initiation of therapy and then every 12 weeks
    a las 9 y a las 18 semanas del inicio del tratamiento y posteriormente cada 12 semanas
    E.5.2Secondary end point(s)
    Clinical benefit rate according to modified RECIST criteria (version 1.1) to treatment with trabectidina.
    Time to progression since the introduction and trabectedin to progression from the start of the subsequent processing based on carboplatin (TTP Pt2) to progression.
    Growth Modulation Index
    Quality of Life
    Safety profile of drugs
    Tasa de beneficio clínico de acuerdo a los criterios RECIST modificados (versión 1.1) al tratamiento con trabectidina.
    Tiempo hasta la progresión desde la introducción de trabectedina hasta la progresión y desde el inicio del subsiguiente tratamiento basado en carboplatino (TTP Pt2) hasta la progresión.
    Growth Modulation Index
    Calidad de vida
    Perfil de seguridad de los fármacos
    E.5.2.1Timepoint(s) of evaluation of this end point
    in all the visits
    en todas las visitas
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    lvlp
    ultima visita ultimo paciente
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    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)
    At 12 weeks the survival information to know the patient is collected, relating to:
    - State vital
    - Additional treatments for ovarian cancer
    A las 12 semanas se recogerá información para conocer la supervivencia de la paciente, relacionada con:
    - Estado vital
    - Tratamientos adicionales para el cáncer de ovario
    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 Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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