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   35177   clinical trials with a EudraCT protocol, of which   5751   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:2017-002767-17
    Sponsor's Protocol Code Number:D0816C00020
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-002767-17
    A.3Full title of the trial
    A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non-Germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy.
    Étude de phase IIIb multicentrique, en ouvert, à bras unique, portant sur l'olaparib en monothérapie d'entretien chez des patientes atteintes d'un cancer de l'ovaire à mutation BRCA non germinale, en rechute et sensible au platine, qui présentent une réponse complète ou partielle suite à une chimiothérapie à base de platine
    Een open-label, multicentrische fase IIIb-studie met één groep van een onderhoudsbehandeling met olaparib in monotherapie bij patiënten met platinagevoelige recidiverende eierstokkanker zonder kiembaanmutatie in BRCA, en die een volledige of gedeeltelijke respons hebben na een
    chemotherapie op basis van platina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non-Germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy
    Étude de phase IIIb multicentrique, en ouvert, à bras unique, portant sur l'olaparib en monothérapie d'entretien chez des patientes atteintes d'un cancer de l'ovaire à mutation BRCA non germinale, en rechute et sensible au platine, qui présentent une réponse complète ou partielle suite à une chimiothérapie à base de platine
    Een open-label, multicentrische fase IIIb-studie met één groep van een onderhoudsbehandeling met olaparib in monotherapie bij patiënten met platinagevoelige recidiverende eierstokkanker zonder kiembaanmutatie in BRCA, en die een volledige of gedeeltelijke respons hebben na een
    chemotherapie op basis van platina
    A.3.2Name or abbreviated title of the trial where available
    OPINION
    A.4.1Sponsor's protocol code numberD0816C00020
    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 SponsorAstraZeneca 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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    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.5.6E-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 No
    D.2.5.1Orphan drug designation number
    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.3.9.3Other descriptive nameOLAPARIB
    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 No
    D.2.5.1Orphan drug designation number
    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.3.9.3Other descriptive nameOLAPARIB
    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.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
    Non Germline BRCA Mutated Ovarian Cancer
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    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 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 by progression-free survival (PFS) (investigator-recorded assessments according to modified Response Evaluation Criteria In Solid Tumors [RECIST v1.1]) of olaparib maintenance monotherapy in non gBRCAm platinum sensitive relapsed (PSR) ovarian cancer
    E.2.2Secondary objectives of the trial
    - Determine efficacy of olaparib maintenance monotherapy in non gBRCAm PSR ovarian cancer by assessment of time to first subsequent therapy or death (TFST)
    - Determine efficacy of olaparib maintenance monotherapy in non gBRCAm PSR ovarian cancer by assessment of time to treatment discontinuation or death (TDT)
    - Determine efficacy by PFS of olaparib maintenance in non gBRCAm PSR ovarian cancer according to tumour HRD status using the Myriad myChoice HRD test
    - Determine efficacy of olaparib maintenance monotherapy in non gBRCAm PSR ovarian cancer by assessment of chemotherapy-free interval (CT-FI)
    - To investigate the Health-related Quality of Life (HRQoL) of non gBRCAm PSR ovarian cancer patients treated with olaparib maintenance monotherapy as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy – Ovarian (FACT-O)

    - To assess the safety and tolerability of olaparib maintenance monotherapy in patients with non gBRCAm PSR ovarian cancer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Patients must be ≥18 years of age
    3. Female patients with histologically diagnosed relapsed HGSOC (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer
    4. Documented gBRCA1/2 mutation status Evidence that the patients do not have a gBRCA mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function). gBRCA1 and/or gBRCA2 variants that are classified as
    "Variants of uncertain clinical significance" or "Variant of unknown significance (VUS)" are eligible, as well as "Variant, favor polymorphism" or "benign polymorphism".
    Evidence of the absence of a somatic BRCA mutation is not required.
    Patients with a tumour BRCA test result only must undergo a gBRCA test to determine whether the BRCA aberration is germline or somatic in origin. If this analysis identifies the aberration as germline the patient is not eligible
    5. Patients must have completed at least 2 previous courses of platinum containing therapy:
    (a) For the penultimate chemotherapy course prior to enrolment on the study:
    • Treatment must have contained a platinum agent (e.g. carboplatin or cisplatin per standard clinical practice; there are no other specific requirements)
    • Patient was platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
    • Maintenance treatment is allowed at the end of the penultimate platinum regimen, including bevacizumab
    (b) For the last chemotherapy course immediately prior to enrolment on the study
    • Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, as defined below, following completion of this chemotherapy course
    • Patient must have received a platinum based chemotherapy regimen (carboplatin or cisplatin) and have received at least 4 cycles of treatment
    • Patients must not have received bevacizumab during this course of treatment
    • Patients must not have received any investigational agent during this course of treatment
    • Patients must initiate treatment within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion)
    6. Pre-treatment CA-125 measurements must meet criterion specified below:
    • If the first value is within upper limit of normal (ULN) the patient is eligible to be enrolled and a second sample is not required
    • If the first value is greater than ULN a second assessment must be performed at least 7 days after the 1st. If the second assessment is ≥ 15% more than the first, the patient is not eligible
    7. Patients must have normal organ and bone marrow function measured within 28 days of starting study treatment, as defined below. In the event of minor deviations from these values which would lead to screen failure, repeat testing within the 28-day screening period (limited to the tests listed below) is allowed before the patient is declared a screen failure.
    8. ECOG performance status 0-1
    9. Patients must have a life expectancy ≥16 weeks
    10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential :negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
    11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
    12. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment
    OR
    No evidence of disease following a complete response to chemotherapy (with or without cytoreductive surgery)
    13. An appropriately prepared tumour sample from the cancer, of sufficient quantity and quality (as specified in the Central Laboratory Services Manual) must be available for future central testing of tumour genetic status. If a recent biopsied sample is provided, the biopsied tumour should not be assessed as target lesions as part of the RECIST assessments if there are other lesions available, and the biopsy should be taken after the baseline scan has been performed. Archival tissue samples may be from the primary tumour or metastatic tumour deposits. Archival bone metastases are not acceptable. Provision of blocks is usually preferred. Any exceptions to these conditions should be discussed with the Sponsor before enrollment of the patient.
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the following exclusion criteria are fulfilled.
    Those asterisked* should be excluded before a request can be considered to perform a gBRCA test prior to full screening. Investigator judgement of patient's potential eligibility to the study should be
    assessed as per Protocol Table 1 and by reviewing the below exclusion criteria).

    1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)*
    2. Previous enrolment in the present study*
    3. Participation in another clinical study with an investigational product (IP) during the most recent chemotherapy course*
    4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to start of study treatment
    5. Any previous treatment with PARP inhibitor, including olaparib*
    6. Patients with a germline BRCA mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function).
    7. 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*
    8. Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks*.
    9. Concomitant use of known strong (e.g., phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5
    weeks for phenobarbital and 3 weeks for other agents*
    10. Persistent toxicities (≥ Grade 2 Common Terminology Criteria for Adverse Event (CTCAE) adverse event) caused by previous cancer therapy, excluding alopecia
    11. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML*
    12. Patients with symptomatic uncontrolled brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have
    received definitive treatment for this and evidence of clinically stable disease (SD) for 28 days*
    13. Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
    14. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
    15. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication*
    16. Currently pregnant (confirmed with a positive pregnancy test) or breastfeeding women*
    17. Immuno-compromised patients e.g., Human Immunodeficiency Virus (HIV) requiring treatment or active Hepatitis B or C*
    18. Patients with a known hypersensitivity to olaparib or any of the excipients of the product*
    19. Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids*
    20. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)*
    21. Patients having gBRCA testing should not have had whole blood transfusions in the last 30 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
    22. Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely or unable to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    PFS: Time from date of first dose until the date of objective radiological disease progression according to modified RECIST 1.1 or death (by any cause in the absence of progression)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At visit 4 and on the first day of each 8 week visit period, relative to the date of the first olaparib dose, for the first 12 months on treatment, and subsequently each 12-week visit period, until the earlier of progression, death or end of study for up to 30 months.
    E.5.2Secondary end point(s)
    (1) - TFST: Time from date of first dose to date of first subsequent treatment commencement or death due to any cause if this occurs before commencement of first subsequent treatment
    (2) - TDT: Time from date of first dose to date of study drug discontinuation or death due to any cause if this occurs before study drug discontinuation
    (3) - PFS in the following subgroups:
    1. Somatic BRCA mutated and HRD scar positive;
    2. HRD scar positive, non-BRCA mutated;
    3. HRD scar negative, non-BRCA mutated
    (4) - CT-FI: Time from the date of the last dose of platinum chemotherapy prior to olaparib maintenance therapy until the date of initiation of the next anticancer therapy
    (5) - Proportion of patients with any improvement from baseline in TOI score
    (6) - Proportion of patients with a 10 point deterioration from baseline in TOI score
    (7) - AE/SAE. Collection of clinical chemistry/haematology parameters.
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) (2) - TFST/TDT : visit 2, 3, 4 and at every tumor assessment visit (TAV), at discontinuation of study drug, at 30 days post last dose, every 12 weeks during long term FUP (up to 30 months)
    (3) - visit 4 and every 8 week for the first 12 months, and each 12 week until earlier progression, death or EOS for up to 30 months
    (4) - Screening, Visit 2, 3, 4 and subsequent TAV, Visit 5 and subsequent safety visits (SV) (at day 85 and then every 8 weeks), until 30 days after last dose and then every 12 weeks until EOS (for up to 30 months)
    (5 and 6) - Visit 2, 3, 4 and at every TAV until progression, at discontinuation of study drug visit and at 30 days post last dose
    (7) - Screening, Visit 2, 3, 4 and subsequent TAV , Visit 5 and subsequent SV, until 30 days after last dose of study drug
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    Israel
    Italy
    Japan
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    The end of the study is defined as 'the last visit of the last patient undergoing the study'.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 113
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    F.4.2.2In the whole clinical trial 250
    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)
    AstraZeneca will continue to supply drug to patients who are deemed to be obtaining benefit by their treating physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic Society of Gyn Oncology (NSGO)
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-09
    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