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    Summary
    EudraCT Number:2017-004323-72
    Sponsor's Protocol Code Number:MedOPP190
    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:2019-12-02
    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 number2017-004323-72
    A.3Full title of the trial
    Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib plus Aromatase Inhibitors for Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Metastatic Breast Cancers with either Germline BRCA-mutated or Germinal BRCA-wild-type and Homologous Recombination Deficiency (HRD) – The LUZERN Strategy –
    Ensayo clínico de fase II, abierto y multicéntrico para evaluar la eficacia y seguridad de niraparib más inhibidores de aromatasa en el cáncer de mama metastásico con receptor hormonal (RH) positivo/receptor del factor de crecimiento epidérmico humano 2 (HER2) negativo con o sin mutación de BRCA en línea germinal y con deficiencia en la recombinación homóloga (HRD) – La estrategia LUZERN.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to evaluate the efficacy and safety of Niraparib + Endocrin Therapy in luminal metastatic breast cancer patients.
    Ensayo clínico para evaluar la eficacia y seguridad de Niraparib + Terapia endocrina en pacientes luminales con cáncer de mama metastásico.
    A.3.2Name or abbreviated title of the trial where available
    LUZERN
    LUZERN
    A.4.1Sponsor's protocol code numberMedOPP190
    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 SponsorMedica Scientia Innovation Research (MedSIR)
    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 supportTesaro,INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedica Scientia Innovation Research (MedSIR)
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Diagonal 211 planta 27
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08018
    B.5.3.4CountrySpain
    B.5.4Telephone number34932214135
    B.5.6E-mailalmudena.garcia@medsir.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 Zejula
    D.2.1.1.2Name of the Marketing Authorisation holderTESARO Bio Netherlands B.V
    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 INNNIRAPARIB
    D.3.9.3Other descriptive nameNIRAPARIB TOSILATE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB183938
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or metastatic HR-positive/HER2-negative breast cancer in
    patients harboring either gBRCAms or gBRCAwt and HRD.
    Cáncer de mama avanzado o metastásico HR-positivo/HER2-negativo en pacientes con gBRCAms o gBRCAwt y HRD.
    E.1.1.1Medical condition in easily understood language
    Luminal advanced or metastatic breast cancer
    Cáncer de mama avanzado o metastásico en pacientes luminales
    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 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10077481
    E.1.2Term Human epidermal growth factor receptor negative
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy –as determined by the clinical benefit rate
    (CBR)– of niraparib in combination with AIs in unresectable locally
    advanced or metastatic HR-positive/HER2-negative breast cancer
    patients harboring either gBRCAms or gBRCAwt and HRD.
    Evaluar la eficacia, determinada por la tasa de beneficio clínico
    (TBC), de niraparib en combinación con IA en pacientes con cáncer
    de mama localmente avanzado irresecable o metastásico con RH
    positivo/HER2 negativo y con gBRCAms o gBRCAwt y HRD.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • To assess the efficacy –as determined by the Progression-free
    Survival (PFS), Objective Response Rate (ORR), time to response
    (TTR), duration of response (DoR), overall survival (OS), and
    maximum tumor reduction– of niraparib in combination with AIs in
    these patients.
    • To evaluate the safety and tolerability of niraparib in combination
    with AIs in these patients.

    Exploratory Objectives:
    • To assess the prevalence of gBRCAms and HRD in these
    patients.
    • To evaluate predictive and/or prognostic biomarkers associated
    with disease activity status or patient outcomes for the
    combination of niraparib and AIs in these patients.
    • To identify possible mechanisms of resistance to the combination
    of niraparib and AIs through the comparative analysis of potential
    biomarkers from paired pre-treatment and post-progression tumor
    biopsies and/or blood samples in these patients.
    Objetivos secundarios:
    • Evaluar en estos pacientes la eficacia de niraparib en combinación
    con IA determinada por la supervivencia libre de progresión (SLP),
    tasa de respuesta objetiva (TRO), tiempo hasta la respuesta (TR),
    duración de respuesta (DR), supervivencia global (SG) y
    reducción máxima del tumor.
    • Evaluar la seguridad y la tolerabilidad de niraparib en combinación
    con IA en estos pacientes.
    Objetivos exploratorios:
    • Evaluar la prevalencia de gBRCAms y HRD en estos pacientes.
    • Evaluar los biomarcadores predictivos o pronósticos asociados al
    estado de actividad de la enfermedad o los resultados en la
    combinación de niraparib e IA en estos pacientes.
    • Identificar los posibles mecanismos de resistencia a la
    combinación de niraparib e IA a través del análisis comparativo
    de los posibles biomarcadores a partir de las biopsias tumorales
    o las muestras de sangre pareadas anteriores al tratamiento y
    posteriores a la progresión en estos pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Male or female patients ≥ 18 years of age. ECOG 0-1
    2. Life expectancy ≥16 weeks.
    3. Patients have radiologic evidence of inoperable locally recurrent or metastatic breast cancer (MBC) that are not candidates for curative intent.
    4. Patients have (HER2)- negative and (HR)-positive breast cancer
    5. [Cohort A]: Patients with documented germinal mutation in BRCA1 or BRCA2 genes Germinal BRCA assays carried out prior to enrollment will be accepted.
    6. [Exploratory cohort B]: Patients with either germinal BRCA1/2 wild-type (gBRCAwt) or gBRCAms that are considered to be non- detrimental and homologous recombination deficiency (HRD) based on the HRDetect predictor test.
    7. [Exploratory cohort B]: Willingness and ability to provide additional six formalin-fixed paraffin-embedded (FFPE) tissue slides from the most recent tumor tissue since last progression (from either metastasis or primary tumor) to centrally perform the RAD51 assay.
    8. At least one and up to two prior lines of endocrine therapy (aromatase inhibitors [AIs] or fulvestrant) for treatment of locally recurrent and/or metastatic disease (except for patients progressing in the neoadjuvant or adjuvant setting).
    9. Confirmed disease progression while in the last AI-containing regimen:
    a. Progression on adjuvant AI-based regimen, confirmed after at least 2 years of ongoing therapy and within 12 months following adjuvant treatment interruption; OR,
    b. Progression to at least one AI-based regimen for treatment of locally recurrent and/or metastatic disease after having achieved clinical benefit (at least 24 weeks on treatment). Confirmation of progression must be within 6 weeks after the end of treatment for locally recurrent and/or metastatic disease.
    10. Patients may have progressed on no more than one chemotherapy regimens in the metastatic setting.
    11. The following will not be counted as a prior line of cytotoxic chemotherapy:
    a. Prior hormonal therapy and non-hormonal targeted therapy.
    b. Targeted and biologic therapies.
    12. The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as this was started at least 5 days prior to study treatment.
    13. Prior carboplatin- or other platinum compound-based therapy is not allowed.
    14. Patients must have evaluable or measurable disease according to (RECIST) criteria version 1.1. Patient with bone-only metastases are eligible.
    15. Willingness and ability to provide the most recent tumor biopsy since last progression from either metastatic or primary tissues both at the time of the inclusion and at disease progression or study termination in order to perform exploratory studies.
    16. Patients must agree to provide blood samples at the time of study inclusion, every three cycles of treatment, and upon disease progression or study termination in order to perform exploratory studies.
    17. Adequate hematologic and organ function within 28 days before the first study treatment on Cycle 1 Day 1
    18. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to study treatment and must agree to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or patients of nonchildbearing potential.
    19. Female patients must agree not to breastfeed during the study and for 180 days after the last dose of study treatment.
    20. Male patients whose partners are women of childbearing potential must use a condom during niraparib therapy and for 90 days after receiving the last dose of niraparib. In addition, men must not donate sperm during niraparib therapy and for 90 days after receiving the last dose of niraparib.
    Criterios de inclusión:
    1. Pacientes de ambos sexos ≥18 años de edad. ECOG 0-1
    2. Esperanza de vida ≥16 semanas.
    3. Pacientes con evidencia radiológica de cáncer de mama localmente recurrente o metastásico (CMM) inoperable que no son candidatos para fines curativos.
    4. Pacientes con cáncer de mama con (HER2) negativo y receptor hormonal (RH) positivo
    5. [Cohorte A]: pacientes con mutación documentada en los genes BRCA1 o BRCA2 en línea germinal. Los resultados de las pruebas de BRCA en línea germinal realizadas antes de la inclusión se aceptarán.
    6. [Cohorte B exploratoria]: los pacientes con BRCA1/2 no mutados o gBRCAms en línea germinal que no se consideren perjudiciales y deficiencia en la recombinación homóloga (HRD) determinada en la prueba predictiva HRDetect.
    7. [Cohorte B exploratoria]: voluntad y capacidad de proporcionar seis cortes adicionales de tejido fijado en formalina y embebido en parafina (FFPE) del tejido tumoral más reciente desde la última progresión (de la metástasis o el tumor primario) para realizar el análisis de RAD51 de manera centralizada.
    8. Como mínimo una y hasta dos líneas previas de tratamiento endocrino (inhibidores de la aromatasa [IA] o fulvestrant) para el tratamiento de la enfermedad localmente recurrente o metastásica (excepto en el caso de los pacientes con progresión en el marco neoadyuvante o adyuvante).
    9. La progresión de la enfermedad confirmada durante la última pauta con IA:
    a. Progresión en la pauta adyuvante con IA, confirmada después de un mínimo de 2 años de tratamiento continuado y durante los 12 meses posteriores a la interrupción del tratamiento adyuvante; o,
    b. progresión como mínimo a una pauta con IA para el tratamiento de la enfermedad localmente recurrente o metastásica una vez alcanzado un beneficio clínico (como mínimo 24 semanas en tratamiento). La confirmación de la progresión se debe producir en el plazo de 6 semanas
    10. Pacientes que progresen con un máximo de una pauta de quimioterapia en caso de metástasis.
    11. Lo siguiente no se considerará una línea anterior de quimioterapia citotóxica:
    a. Tratamiento hormonal anterior y tratamiento no hormonal dirigido.
    b. Tratamientos dirigidos y biológicos.
    12. El paciente puede recibir una dosis estable de bifosfonatos o denosumab para las metástasis óseas, antes y durante el estudio, siempre y cuando se haya iniciado al menos 5 días antes del tratamiento del estudio.
    13. El tratamiento previo con carboplatino u otro compuesto de platino no está autorizado.
    14. Los pacientes deben presentar una enfermedad evaluable o medible de acuerdo con (RECIST) versión 1.1. Los pacientes que solo presentan metástasis óseas son elegibles.
    15. Voluntad y capacidad de proporcionar la biopsia tumoral más reciente desde la última progresión de los tejidos metastásicos o primarios tanto en el momento de la inclusión como en la progresión de la enfermedad o la finalización del estudio para realizar estudios exploratorios.
    16. Los pacientes deben aceptar proporcionar muestras de sangre en el momento de la inclusión en el estudio, cada tres ciclos de tratamiento y cuando se produzca la progresión de la enfermedad o la finalización del estudio para realizar estudios exploratorios.
    17. Función hematológica y orgánica adecuada durante los 28 días anteriores al primer tratamiento del estudio el día 1 del ciclo 1
    18. Pacientes en edad fértil deben presentar un resultado negativo en una prueba de embarazo en suero realizada durante los 7 días anteriores al tratamiento del estudio y deben aceptar abstenerse de realizar actividades que puedan resultar en embarazo desde la selección hasta 180 días después de la última dosis del tratamiento del estudio o pacientes que no se encuentren en edad fértil
    19. Las pacientes mujeres deberán aceptar no dar el pecho durante el estudio ni durante los 180 días posteriores a la última dosis del tratamiento del estudio.
    20. Los pacientes varones cuyas parejas sean mujeres en edad fértil deben utilizar un preservativo durante el tratamiento con niraparib y durante los 90 días posteriores a la última dosis de niraparib. Asimismo, los hombres no deben donar esperma durante el tratamiento con niraparib ni durante los 90 días posteriores a la última dosis de niraparib.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. HER2-positive disease based on local laboratory results (performed by IHC/in situhybridization test) or unknown HER2 status.
    2. Patients that are candidates for a local treatment with a radical intention.
    3. Patients that have previously received any PARP inhibitor (PARPi), including niraparib, in metastatic setting.
    4. Patients must not be simultaneously enrolled in any interventional clinical trial and must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
    5. Patients who have had radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to start of treatment, excepting for palliative radiation therapy to a small field >1 week prior to Day 1 of study.
    6. Patients with visceral crisis who require chemotherapy.
    7. Patients must not have a known hypersensitivity to niraparib components or excipients.
    8. Patients must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
    9. Patients must not have received colony-stimulating factors within 4 weeks prior initiating protocol therapy.
    10. Patients have had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy in adjuvant setting or cyclin-dependent kinases (CDK)4/6inhibitors that persisted > 4 weeks and was related to the most recent treatment.
    11. Patients must not have any known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
    12. Patients with symptomatic uncontrolled brain metastases or leptomeningealmetastases.
    13. Patients must not have had diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy
    14. Patients with symptomatic uncontrolled brain metastases or leptomeningeal metastases.
    15. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
    16. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    17. Chronic daily treatment with corticosteroids with a dose of ≥ 10 mg/day methylprednisolone equivalent (excluding inhaled steroids), except for prophylaxis use.
    18. Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods.
    Criterios de exclusión:
    1. Enfermedad con HER2 positivo basada en los resultados del laboratorio local (obtenidos mediante la prueba de IHC/hibridación in situ) o estado de HER2 desconocido.
    2. Pacientes que son candidatos a un tratamiento local con intención radical.
    3. Pacientes que han recibido anteriormente un inhibidor de PARP (iPARP), incluidoniraparib, en caso de metástasis.
    4. Los pacientes no deben estar incluidos simultáneamente en ningún ensayo clínico intervencionista y no deben haber recibido ningún tratamiento en investigación en ≤4 semanas, o en un intervalo de tiempo inferior a 5 vidas medias del fármaco en investigación, aquel periodo que sea más breve, antes de iniciar el tratamiento del protocolo.
    5. Pacientes que hayan recibido radioterapia que afecte >20 % de la médula ósea durante las dos semanas anteriores al inicio del tratamiento, excepto radioterapia paliativa en una zona pequeña >1 semana antes del día 1 del estudio.
    6. Pacientes con crisis visceral que requieran quimioterapia.
    7. Los pacientes no deben presentar hipersensibilidad a los componentes o excipientes de niraparib.
    8. Los pacientes no deben haber recibido una transfusión (plaquetas o eritrocitos) ≤4 semanas antes de iniciar el tratamiento del protocolo.
    9. Los pacientes no deben haber recibido factores estimulantes de colonias durante las 4 semanas anteriores al inicio del tratamiento del protocolo.
    10. Los pacientes han presentado anemia, neutropenia o trombocitopenia de grado 3 o 4 debido a una quimioterapia anterior en el contexto adyuvante o inhibidores 4/6 de quinasas dependientes de ciclinas (CDK) que ha persistido >4 semanas y se ha relacionado con el tratamiento más reciente.
    11. Los pacientes no deben presentar antecedentes del síndrome mielodisplásico (SMD) nide leucemia mieloide aguda (LMA).
    12. Los pacientes no deben presentar ningún trastorno médico grave y no controlado,enfermedad sistémica no maligna o infección activa no controlada.
    13. Los pacientes no deben haber presentado ningún diagnóstico, detección o tratamientode otro tipo de cáncer ≤2 años antes de iniciar el tratamiento del protocolo
    14. Pacientes con metástasis cerebrales sintomáticas y no controladas o metástasis leptomeníngeas.
    15. Trasplante alogénico de médula ósea o trasplante doble de sangre de cordón umbilical (TDSC) anteriores.
    16. Pacientes con trastornos gastrointestinales que pudieran interferir con la absorción de la medicación del estudio.
    17. Tratamiento diario crónico con corticosteroides con una dosis equivalente a ≥10 mg/día de metilprednisolona (excepto esteroides inhalados), salvo que se utilice con fines profilácticos.
    18. Pacientes embarazadas o en periodo de lactancia, o adultas en edad fértil que no utilicen ningún método anticonceptivo eficaz.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    • CBR defined as the percentage of patients who experience a
    complete response (CR), partial response (PR) or stable disease
    (SD) for at least 24 weeks. CBR will be assessed locally by the
    Investigator through the use of RECIST v.1.1 criteria.
    La TBC se define como el porcentaje de pacientes que presentan
    una respuesta completa (RC), respuesta parcial (RP) o
    enfermedad estable (EE) durante un mínimo de 24 semanas. El investigador evaluará la TBC de manera local mediante el uso de
    los criterios de RECIST v.1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to disease progression.
    Desde la randomización hasta progresión de la enfermedad.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • The efficacy will be evaluated by PFS, ORR, TTR, DoR, OS, and maximum tumor reduction. PFS, ORR, TTR, DoR, and maximum tumor reduction will be assessed locally by the Investigator through the use of RECIST v.1.1 criteria.
    • The safety and tolerability will be evaluated by incidence of adverse events (AEs), prespecified AEs, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
    Exploratory Endpoints:
    • The number of patients harboring either gBRCAms
    (distinguishing between deleterious or suspected deleterious
    mutations in BRCA1 and BRCA2 genes), or gBRCAwt and HRD
    (distinguishing among different genomic signatures) divided by
    the total number of patients in the analysis set.
    • The number of patients harboring either gBRCAms
    (distinguishing between deleterious or suspected deleterious
    mutations in BRCA1 and BRCA2 genes), or gBRCAwt and HRD
    (distinguishing among different genomic signatures) who obtain
    clinical benefit divided by the total number of patients in the
    analysis set.
    • Association of prognostic and/or predictive, tumor- and/or
    immune-related biomarkers in tumor biopsies and/or blood
    samples with CBR, PFS, ORR, TTR, DoR, OS, and maximum
    tumor reduction.
    • Association of biomarkers indicators of drug resistance in paired
    pre-treatment and post-progression tumor biopsies and/or blood
    samples with CBR, PFS, ORR, TTR, DoR, OS, and maximum
    tumor reduction.
    Variables secundarias:
    • La eficacia se evaluará según la SLP, TRO, TR, DR, SG y
    reducción máxima del tumor. El investigador evaluará la SLP,
    TRO, TR, DR y reducción máxima del tumor de manera local
    según los criterios RECIST v.1.1.
    • Se evaluarán la seguridad y tolerabilidad según la incidencia de
    acontecimientos adversos (AA), AA previamente especificados,
    cambio respecto a la basal en las constantes vitales objetivo y
    cambio respecto a la basal en los resultados de las pruebas
    analíticas objetivo según los criterios de terminología común de
    acontecimientos adversos (CTCAE) v.5.0 del National Cancer
    Institute (NCI) de EE. UU.
    Variables exploratorias:
    • El número de pacientes que presentan gBRCAms (distinguiendo
    entre mutaciones deletéreas o sospecha de ello en los genes
    BRCA1 y BRCA2) o gBRCAwt y HRD (distinguiendo entre firmas
    genómicas diferentes) dividido entre el número total de pacientes
    en el grupo de análisis.
    • El número de pacientes que presentan gBRCAms (distinguiendo
    entre mutaciones deletéreas o sospecha de ello en los genes
    BRCA1 y BRCA2) o gBRCAwt y HRD (distinguiendo entre firmas
    genómicas diferentes) que obtienen beneficio clínico dividido
    entre el número total de pacientes en el grupo de análisis.
    • Asociación de biomarcadores pronósticos o predictivos,
    tumorales o inmunológicos en las biopsias tumorales o las
    muestras de sangre con TBC, SLP, TRO, TR, DR, SG y reducción
    máxima del tumor.
    • Asociación de indicadores de biomarcadores de resistencia al
    fármaco en biopsias tumorales o muestras de sangre pareadas
    anteriores al tratamiento y posteriores a la progresión con TBC,
    SLP, TRO, TR, DR, SG y reducción máxima del tumor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from randomization to disease progression.
    Desde la randomización hasta progresión de la enfermedad.
    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 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
    EoS is estimated to occur up to 5 years after last patient included in
    the study
    Se prevé que el FE se producirá hasta 5 años después de la inclusión
    del último paciente en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state23
    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)
    Standard of Care
    Práctica Clínica habitual
    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 Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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