Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-003438-20
    Sponsor's Protocol Code Number:D0816C00010
    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:2015-04-14
    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 number2014-003438-20
    A.3Full title of the trial
    A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician?s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients carrying germline BRCA1/2 Mutations
    Estudio abierto, multicéntrico, controlado y aleatorizado de fase III para evaluar la eficacia y seguridad del olaparib en monoterapia frente a la quimioterapia con agente único de elección por el médico en el tratamiento del cáncer ovárico recidivante sensible al platino en pacientes portadoras de las mutaciones germinales BRCA1/2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib Monotherapy versus Physician?s Choice Chemotherapy in the Treatment of Ovarian Cancer in Patients carrying BRCA Mutations
    Olaparib en monoterapia frente a la quimioterapia en el tratamiento del cáncer ovárico en pacientes que portan mutaciones BRCA.
    A.3.2Name or abbreviated title of the trial where available
    SOLO3
    SOLO3
    A.4.1Sponsor's protocol code numberD0816C00010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02282020
    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 SponsorAstra Zeneca AB
    B.1.3.4CountrySweden
    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 supportAstra Zeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstra Zeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.4Telephone number900 811 335
    B.5.6E-mailinformation.center@astrazeneca.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/501
    D.3 Description of the IMP
    D.3.1Product nameOlaparib
    D.3.2Product code AZD2281
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/501
    D.3 Description of the IMP
    D.3.1Product nameOlaparib
    D.3.2Product code AZD2281
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 RoleComparator
    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.2.5The 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 namepaclitaxel
    D.3.4Pharmaceutical form Concentrate for 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 INNpaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 namePegylated liposomal doxorubicin hydrochloride
    D.3.4Pharmaceutical form Concentrate for 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 INNdoxorubicin hydrochloride
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nametopotecan
    D.3.4Pharmaceutical form Concentrate for 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 INNtopotecan hydrochloride
    D.3.9.1CAS number 119413-54-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameGemcitabine
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNgemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-09
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number38 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.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
    Platinum Sensitive Relapsed Ovarian Cancer
    Cáncer ovárico en recaída sensible al platino
    E.1.1.1Medical condition in easily understood language
    ovarian cancer
    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 17.1
    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
    To determine the efficacy of Olaparib vs. physician?s choice single agent chemotherapy by assessment of progression free survival using blinded independent central review.
    Determinar la eficacia de olaparib frente a la quimioterapia con un agente único de elección del médico según evaluación de la
    supervivencia libre de progresión mediante revisión centralizada independiente enmascarada.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of single agent olaparib versus physician s choice single agent chemotherapy by assesment of:
    ?Overall Survival,
    ?Time to second progression,
    ?Time to earliest progression by RECIST or CA-125 or death,
    ?Time to first subsequent therapy or death,
    ?Time to second subsequent therapy or death,
    ?Time to study treatment discontinuation or death;

    To compare the efficacy of single agent olaparib versus physician?s choice single agent chemotherapy on the Health-related Quality of Life

    To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (e.g. gene sequencing and large rearrangement analysis).
    Determinar la eficacia de olaparib frente a la quimioterapia con un agente único de elección del médico según evaluación de:
    -Supervivencia global,
    -Tiempo hasta la segunda progresión
    -Tiempo hasta la progresión más temprana según RECIST 1.1 o CA-125 o
    el fallecimiento,
    -Tiempo entre el primer tratamiento posterior o el fallecimiento,
    -Tiempo entre el segundo tratamiento subsecuente o el fallecimiento,
    -Tiempo entre la suspensión del tratamiento o el fallecimiento,
    Comparar la eficacia de olaparib en monoterapia frente a quimioterapia con un agente único de elección del médico en la calidad de vida relacionada con la salud.
    Evaluar la eficacia de olaparib en pacientes en las que se detecta una variante nociva o sospechosamente nociva en cualquiera de los genes de BRCA con variantes identificadas mediante ensayos de mutaciones de BRCA actuales o futuros (p. ej., secuenciación génica y análisis de
    reordenación amplia).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients must be >= 18 years of age during randomisation
    -Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer
    -Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
    -At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
    -Patients must have received at least 2 prior platinum based previous lines of chemotherapy for ovarian cancer prior randomisation
    -Patients must be partially platinum sensitive (defined as progression 6 -12 months after the end of the last platinum based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum based chemotherapy).
    -Patients must be suitable to start treatment with single agent chemotherapy based on physician?s choice of weekly paclitaxel or topotecan or pegylated liposomal doxorubicin or gemcitabine.
    -Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
    - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    - Patients must have a life expectancy >= 16 weeks
    -Postmenopausal or evidence of non-childbearing status for women of childbearing potential
    -Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
    -Las pacientes deben tener >= 18 años de edad durante la aleatorización.
    -Las pacientes con cáncer ovárico seroso de gran malignidad con recidiva y diagnóstico histológico (incluido cáncer peritoneal primario y/o de trompas de Falopio) o cáncer de endometrio de gran malignidad.
    -Mutación en la línea germinal documentada del gen BRCA1 y/o BRCA2 que se prevea que puede ser nociva o sospechosamente nociva (se sabe o se prevé que es nocivo/puede provocar una pérdida de función).
    -Al menos una lesión (cuantificable y/o no cuantificable) que pueda evaluarse de forma precisa al inicio mediante TC/RM y sea adecuada para la repetición de la evaluación.
    -Las pacientes deben haber recibido al menos 2 líneas de quimioterapia basada en platino previas para el cáncer de ovario, antes de la aleatorización.
    Las pacientes deben ser parcialmente sensibles al platino (definido como progresión 6-12 meses después de la última quimioterapia basada en platino) o sensibles al platino (definida como progresión > 12 meses después de la última quimioterapia basada en platino).
    -Las pacientes deberán ser aptas para iniciar tratamiento con quimioterapia con un solo fármaco basada en la elección del médico de paclitaxel, topotecán, doxorubicina liposómica pegilada o gemcitabina semanal.
    -Las pacientes deben presentar función orgánica y medular normal determinada en los 28 días previos a la aleatorización,
    -Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 a 2,
    -Las pacientes deben tener una esperanza de vida >= 16 semanas
    -Posmenopáusicas o signos de ausencia de embarazo en edad fértil: prueba de embarazo en orina o suero negativo en los 7 días previos a la primera dosis del fármaco del estudio,
    -Debe haber una muestra tumoral fijada en formalina e incluida en parafina (FFIP) del cáncer primario o recidivante para análisis centralizado.
    E.4Principal exclusion criteria
    BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., ?Variants of uncertain clinical significance? or ?Variant of unknown significance? or ?Variant, favor polymorphism? or ?benign polymorphism? etc.)
    -Previous randomisation in the present study
    -Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
    -Any previous treatment with a PARP inhibitor, including olaparib.
    -Patients who have platinum resistant or refractory disease
    -Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ?5 years. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to randomisation
    -Clinical significant abnormality on resting ECG
    - Patients receiving any systemic chemotherapy within 3 weeks prior to first randomisation (or a longer period depending on the defined characteristics of the agents used) or radiotherapy within 2 weeks prior to randomisation.
    -Previous single agent exposure to the selected chemotherapy regimen for randomisation
    -Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
    -Persistent toxicities (> Common Terminology Criteria for Adverse Event grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy.
    -Patients with myelodysplastic syndrome/treatment related acute myeloid leukaemia (t-AML)
    -Patients with symptomatic uncontrolled brain metastases.
    -Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    -Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
    -Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    -Breastfeeding women.
    -Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    -Patients with known active hepatitis B or C or HIV.
    -Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation
    -Whole blood transfusions in the last 120 days prior to randomisation.
    -Mutaciones en BRCA1 y/o BRCA2 que no se consideren nocivas (p. ej.,"variantes de significación clínica incierta" o "variante de significación desconocida" o "variante tendente a polimorfismo" o "polimorfismo benigno", etc.)
    -Aleatorización previa en el presente estudio,
    -Exposición a cualquier producto en investigación en los 30 días o en 5 semividas (lo que sea más largo) anteriores a la aleatorización,
    -Cualquier tratamiento previo con un inhibidor de la PARP, incluido olaparib,
    -Pacientes con enfermedad resistente al platino o refrectaria.
    -Otras neoplasias malignas en los 5 años previos, salvo cáncer de piel distinto de melanoma tratado de forma adecuada, cáncer del cuello uterino in situ tratado de forma curativa, carcinoma ductal in situ (DCIS), carcinoma endometrial de grado 1 en estadio 1 u otros tumores
    sólidos, incluidos linfomas (sin afectación de la médula ósea) tratados de forma curativa sin signos de enfermedad durante ? 5 años; las pacientes con cáncer de mama triple negativo primario podrán ser elegibles siempre que hayan finalizado su tratamiento definitivo más de 3 años antes y permanezcan sin cáncer de mama antes de la aleatorización
    -ECG en reposo con signos clínicamente anómalos
    -Las pacientes que reciban cualquier quimioterapia sistémica en las 3 semanas previas a la primera dosis del tratamiento del estudio (o un período superior dependiendo de las características definidas de los fármacos utilizados) o radioterapia en las 2 semanas previas a la primera dosis del tratamiento del estudio,
    -Exposición previa en monoterapia a la pauta de quimioterapia seleccionada para la aleatorización.
    -Uso concomitante de inhibidores potentes conocidos de CYP3A4/5, como ketoconazol, itraconazol, ritonavir, indinavir, saquinavir, telitromicina, claritromicina y nelfinavir
    -Toxicidades persistentes (grado > 2 según los Criterios terminológicos comunes para acontecimientos adversos [CTCAE]) causadas por tratamiento antineoplásico previo, excepto alopecia y neuropatía periférica de grado 2 según los CTCAE,
    -Pacientes con síndrome mielodisplásico/leucemia mieloide aguda relacionada con el tratamiento (LMA-t)
    -Pacientes con metástasis cerebrales no controladas sintomáticas,
    -Cirugía mayor en las 2 semanas previas al inicio del tratamiento del estudio y las pacientes deben haberse recuperado de todos los efectos de cualquier cirugía mayor.
    -Las pacientes incapaces de tragar la medicación de administración por vía oral y las pacientes con trastornos digestivos que podrían interferir en la absorción de la medicación del estudio.
    -Mujeres en período de lactancia.
    -Pacientes con hipersensibilidad conocida a olaparib o cualquiera de los excipientes del producto
    -Pacientes con hepatitis B o C o VIH activos conocidos
    -Alotrasplante medular previo o doble trasplante de sangre de cordón umbilical
    -Transfusiones de sangre entera en los 120 días previos a la
    aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) by BICR using RECIST 1.1
    Supervivencia libre de Progresión (SSP) por evaluación radiológica por RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline assessment - as close as possible to start of study treatment; subsequent assessments - at the end of every 8 weeks (+/- 1 week) from randomisation for 48 weeks and every 12 weeks thereafter until radiological disease progression
    Las evaluaciones basales- lo más cerca posible de empezar el
    tratamiento del estudio; Evaluaciones subsecuentes- al final o cada 8 semanas (+/-1semana) desde la aleatorización durante 48 semanas y después cada 12 semanas hasta progresión radiológica de la enfermedad.
    E.5.2Secondary end point(s)
    1) Overall Survival (OS)
    2)Time from randomisation to second progression (PFS2)
    3)Time to earliest progression by CA-125 or death
    4)Time to earliest progression by RECIST or death
    5)Time from randomisation to first subsequent therapy or death (TFST)
    6)Time from randomisation to second subsequent therapy or death (TSST)
    7)Time from randomisation to study treatment discontinuation or death (TDT)
    8) Patient Reported Outcome (HQoL): FACT-O, TOI
    1)Supervivencia Global
    2)Tiempo desde la aleatorización a la segunda progresión
    3)Tiempo desde la primera progresión por CA-125 o fallecimiento
    4)Tiempo desde la primera progresión por RECIST o fallecimiento
    5)Tiempo desde la aleatorización a la primera terapia posterior o fallecimiento
    6)Tiempo desde la aleatorización a la secunda terapia posterior o fallecimiento
    7)Tiempo desde la aleatorización a la finalización del tratmiento o fallecimiento.
    8)Resultados comunicados por la paciente(CdVRS):FACT-0, TOI
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 5, 6, 7: after study treatment discontinuation at first progression, 12 weeks thereafter
    3: baseline,4 weeks after until PFS or death
    4: baseline, then every 8 weeks up to 48 weeks, then every 12 weeks, additional assessment after first progression: after 8 weeks
    8: baseline, at day 29, and in line with RECIST until disease progression, every 12 weeks after study treatment discontinuation
    1,2,5,6,7; después de la finalización del tratamiento del estudio por la primera progresión, despues cada 12 semanas
    3:basal, 4 semanas después, hasta superviviencia libre de progresión o fallecimiento
    4:basal, cada 8 semanas hasta 48 semanas, después cada 12 semanas, evaluación adicional despues de la primera progresión: después de 8 semanas.
    8:basal, en el día 29 y en linea con los RECIST hasta progresión de la enfermedad, cada 12 semanas después de la finalización del tratamiento 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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Quimioterapia estándar de agente único
    single agent standard chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Argentina
    Belgium
    Brazil
    Canada
    Czech Republic
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the date of the last visit of the last patient undergoing the study
    La fecha de la última visita del último paciente en tratamiento en el
    estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 309
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 411
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA