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    Summary
    EudraCT Number:2017-004166-10
    Sponsor's Protocol Code Number:CO-338-085
    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:2018-03-14
    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 number2017-004166-10
    A.3Full title of the trial
    A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
    Estudio abierto de fase II con rucaparib en pacientes con carcinoma urotelial localmente avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
    Estudio con rucaparib en pacientes con carcinoma urotelial localmente avanzado o metastásico
    A.3.2Name or abbreviated title of the trial where available
    ATLAS
    ATLAS
    A.4.1Sponsor's protocol code numberCO-338-085
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03397394
    A.5.4Other Identifiers
    Name:US INDNumber:129840
    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 SponsorClovis Oncology, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClovis Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClovis Oncology UK Ltd
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressSheraton House, Castle Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB3 0AX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401223370 037
    B.5.6E-mailinfo@clovisoncology.com
    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 nameRucaparib 200 mg
    D.3.2Product code CO-338
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.3Other descriptive nameRucaparib
    D.3.9.4EV Substance CodeSUB74859
    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.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 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 nameRucaparib 250 mg
    D.3.2Product code CO-338
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.3Other descriptive nameRUCAPARIB
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 nameRucaparib 300 mg
    D.3.2Product code CO-338
    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 INNRucaparib
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    D.3.9.3Other descriptive nameRUCAPARIB
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Metastatic Urothelial Carcinoma
    Carcinoma urotelial localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    bladder cancer
    cancer de vejiga
    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 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10044412
    E.1.2Term Transitional cell carcinoma
    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
    The primary objective for this study is:
    • To evaluate objective response rate (ORR) in molecularly-defined homologous
    recombination deficiency (HRD)-positive and intent-to-treat (ITT) populations using a prospectively defined molecular signature.
    El objetivo primario de este estudio es:
    • Evaluar la tasa de respuesta objetiva (ORR) en poblaciones con deficiencia de la recombinación homóloga (DRH+) definida molecularmente y con intención de tratar (ITT) de forma prospectiva por medio de una firma molecular definida.
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are:
    • To evaluate duration of response (DOR)
    • To estimate progression-free survival (PFS)
    • To estimate overall survival (OS)
    • To evaluate safety and tolerability of rucaparib
    • To evaluate steady-state pharmacokinetics (PK) of rucaparib
    Los objetivos secundarios de este studio son:
    •Evaluar la duración de la respuesta (DdR).
    •Calcular la supervivencia libre de progresión (SLP).
    •Calcular la supervivencia global (SG).
    •Evaluar la seguridad y la tolerabilidad del rucaparib.
    •Evaluar los parámetros farmacocinéticos (FC) en estado de equilibrio del rucaparib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have histologically or cytologically confirmed locally advanced or
    metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter,
    urinary bladder or urethra)
    • Received 1 or 2 prior standard of care regimens for advanced or metastatic
    disease
    • Confirmed radiologic disease progression during or following recent
    treatment
    • Mandatory biopsy is required during screening
    • Measurable disease per RECIST v1.1
    • Adequate organ function
    • ECOG 0 or 1
    •tener un carcinoma de células transicionales del urotelio (pelvis, renal, ureter, vejiga urinario o uretra) localmente avanzado o metastásico y confirmado citológica o histologicamente
    •haber recibido previamente 1 o 2 regimens de tratamiento standard para la enfermedad avanzada o metastásica
    •confirmación radiológica de la progression de la enfermedad durante o tras reciente tratamiento
    •biopsis durante la selección es obligatoria
    •enfermedad cuantificable por RECIST v1.1
    •function orgánica adecuada
    •ECOG 0 o 1
    E.4Principal exclusion criteria
    • Prior treatment with a PARP inhibitor
    • Symptomatic and/or untreated CNS metastases
    • Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
    •Tratamiento previo con inhibidor PARP
    •Metástasis sintomáticas y/o no tratatdas del sistema nervioso central
    •stent duodenal preexistente y/o cualquier defecto o trastorno gastrointestinal que pudiera interferir e la absorción de rucaparib.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of ORR is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. The ORR will be summarized with frequencies and percentages for the ITT and HRD-positive populations as well as other HRD subgroups.

    La evaluación de eficacia primaria TRO se define como la mejor respuesta confirmada de CR o PR por RECIST v1.1 evaluada por el investigador. El TRO se resumirá con frecuencias y porcentajes para las poblaciones ITT y DRH-positivas, así como para otros subgrupos de DHR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments will be performed during screening (baseline), at the end of every 8 calendar weeks (±7 days) relative to the first dose of rucaparib (Cycle 1 Day 1) up to 18 months, then every 12 calendar weeks (±7 days), until confirmed radiologic disease progression by RECIST v1.1 criteria, as assessed by the investigator.
    las evaluaciones del tumor serán realizadas durante la selección (linea de base), al final de cada 8 semanas naturales (±7 días) en relación a la primera dosis de rucaparib ( ciclo 1 dia 1) hasta 18 meses, entonces cada 12 semanas naturales (±7 días), hasta la confirmación radiológica de la progression de la enfermedad segín criterio RECIST v1.1, llevado a cabo por el investigador
    E.5.2Secondary end point(s)
    Efficacy:
    Duration of Response (DOR):
    Duration of confirmed response is defined as the time from the date that a response is first reported to the time that progression is first documented after the confirmed response.

    Progression-free Survival (PFS):
    PFS will be calculated as 1+ the number of days from the first dose of rucaparib to disease progression or death due to any cause, whichever occurs first.
    Patients without a documented event of progression will be censored on the date of their last adequate tumor assessment (ie, radiologic assessment) or date of first dose of rucaparib if no post-baseline tumor assessments have been performed.

    Overall Survival (OS):
    Overall survival (OS) is defined as the date from first dose of rucaparib to the date of death due to any cause. Patients who have not died will be censored at the date last known to be alive.

    Safety:
    Safety endpoints include incidence of AEs, clinical laboratory abnormalities, and dose modifications.
    Data from all patients in the safety population will be included in the safety analyses. AEs, clinical laboratory results, vital signs, ECG results, ECOG performance status, body weight, and concomitant medications/ procedures will be tabulated and summarized.

    PK:
    The PK data and selected safety and efficacy endpoints will be included in exploratory population PK and exposure-response analyses, and the results will be reported separately.
    Eficacia:
    Duración de la respuesta (DdR):
    La duración de la respuesta confirmada se define como el tiempo desde la fecha en que se informa por primera vez una respuesta hasta el momento en que la progresión se documenta por primera vez después de la respuesta confirmada.

    Supervivencia libre de progresión (SLP):
    PFS se calculará como 1+ el número de días desde la primera dosis de rucaparib hasta la progresión de la enfermedad o muerte por cualquier causa, lo que ocurra primero.
    Los pacientes sin un evento de progression documentado serán censurados en la fecha de su última evaluación tumoral adecuada (es decir, evaluación radiológica) o la fecha de la primera dosis de rucaparib si no se han realizado evaluaciones tumorales posteriores a la línea de base.

    Supervivencia global (SG):
    La supervivencia global (SG) se define como la fecha desde la primera dosis de rucaparib hasta la fecha de muerte debido a cualquier causa. Los pacientes que no hayan muerto serán censurados en la fecha en que se sabe que está vivo.

    La seguridad:
    Los criterios de valoración de seguridad incluyen la incidencia de eventos adversos, anomalías de laboratorio clínico y modificaciones de la dosis.
    Los datos de todos los pacientes en la población de seguridad se incluirán en los análisis de seguridad. Se tabularán y resumirán los efectos adversos, los resultados del laboratorio clínico, los signos vitales, los resultados del ECG, el estado funcional del ECOG, el peso corporal y los medicamentos / procedimientos concomitantes.

    FC:
    Los datos farmacocinéticos y los criterios de seguridad y eficacia se incluirán en la población exploratoria PK y en los análisis de exposición-respuesta, y los resultados se informarán por separado.




    Eficacia:
    Duración de la respuesta (DdR):
    La duración de la respuesta confirmada se define como el tiempo desde la fecha en que se informa por primera vez una respuesta hasta el momento en que la progresión se documenta por primera vez después de la respuesta confirmada.

    Supervivencia libre de progresión (SLP):
    SLP se calculará como 1+ la cantidad de días desde la primera dosis de rucaparib hasta la progresión de la enfermedad o muerte por cualquier causa, lo que ocurra primero.
    Los pacientes sin un evento documentado de progresión serán censurados en la fecha de su última evaluación tumoral adecuada (es decir, evaluación radiológica) o la fecha de la primera dosis de rucaparib si no se han realizado evaluaciones tumorales posteriores a la línea de base.

    Supervivencia global (SG):
    La supervivencia global (SG) se define como la fecha desde la primera dosis de rucaparib hasta la fecha de muerte debido a cualquier causa. Los pacientes que no hayan muerto serán censurados en la fecha en que se sabe que está vivo.

    La seguridad:
    Los criterios de valoración de seguridad incluyen la incidencia de eventos adversos, anomalías de laboratorio clínico y modificaciones de la dosis.
    Los datos de todos los pacientes en la población de seguridad se incluirán en los análisis de seguridad. Se tabularán y resumirán los efectos adversos, los resultados del laboratorio clínico, los signos vitales, los resultados del ECG, el estado funcional del ECOG, el peso corporal y los medicamentos / procedimientos concomitantes.

    FC:
    Los datos farmacocinéticos y los puntos finales seleccionados de seguridad y eficacia se incluirán en la población exploratoria FC y en los análisis de exposición-respuesta, y los resultados se informarán por separado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    DOR, PFS, OS please refer to E.5.2

    Safety;
    The investigator has the responsibility for assessing the safety of the patients and for compliance with the protocol to ensure study integrity. During the screening period, unless otherwise required by local regulations, SAEs which are related to protocol-mandated assessments will be reported. Once enrolled and rucaparib is administered, patients will be monitored for all AEs/SAEs/AESIs during study participation and until 28 days after the last dose of rucaparib. After the 28-day window, only treatment-related SAEs and all AESIs, irrespective of causality, need to be reported.

    PK:
    Plasma samples are to be collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
    DdR, SLP, SG, consulte E.5.2
    seguridad:El investigador tiene la responsabilidad de evaluar la seguridad de los pacientes y del cumplimiento del protocolo para garantizar la integridad del estudio. Durante el período de selección, se informarán los AAGs relacionados con las evaluaciones del protocolo. Una vez que se incluya y se administre rucaparib, se controlará a los pacientes para detectar todos los AA / AAG / AAIE durante la participación en el estudio y hasta 28 días tras la última dosis . Después de la ventana de 28 días, solo deben informarse los AAG y AAIE relacionados con el tratamiento .
    PK: Se deben tomar muestras de plasma para el análisis PK a nivel de rucaparib 1 hora antes de la dosis de la mañana en el Ciclo 2 Día 1, Ciclo 3 Día 1 y Ciclo 4 Día 1
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    última visita del 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 200
    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)
    Patients will take rucaparib BID for continuous 28-day cycles until disease progression as assessed by the investigator, or other reason for discontinuation.
    All patients discontinued from treatment, regardless of reason, will be followed and information collected for subsequent treatments and survival every 12 weeks from last dose of rucaparib until death, loss to follow-up, withdrawal of consent from study, or closure of the study.
    Los pacientes tomarán rucaparib durante ciclos continuos de 28 días hasta la progresión de la enfermedad evaluada por el investigador, u otra razón para la interrupción.Todos los pacientes descontinuados del tratamiento, independientemente de la razón, serán seguidos y se recopilará información de tratamientos posteriores y supervivencia cada 12 semanas desde la última dosis de rucaparib hasta la muerte, pérdida durante el seguimiento, retirada del consentimiento o el cierre del estudio
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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