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    The EU Clinical Trials Register currently displays   39602   clinical trials with a EudraCT protocol, of which   6490   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2015-000734-30
    Sponsor's Protocol Code Number:D0816C00012
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-000734-30
    A.3Full title of the trial
    An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed somatic or germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy (ORZORA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Label, Single Arm, Multicentre Study of Lynparza (Olaparib) Capsules in Relapsed BRCA Mutated Ovarian Cancer Patients (ORZORA)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD0816C00012
    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.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.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
    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. name Lynparza
    D. of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLynparza
    D.3.2Product code AZD2281(KU-0059436)
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281 (KU-0059436)
    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 number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    BRCA or HRR+ Mutated Ovarian Cancer Patients
    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 assess the real world clinical effectiveness of olaparib maintenance monotherapy by investigator assessed progression free survival (PFS) according to modified Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 in patients with sBRCAm ovarian cancer. To assess the real world clinical effectiveness of olaparib maintenance monotherapy by investigato assessed PFS according to RECIST 1.1 in patients with BRCAm ovarian cancer.
    E.2.2Secondary objectives of the trial
    - To assess the real world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer, by assessment of:
    - overall survival (OS),
    - time toinvestigator- assessed second progression (PFS2), or death.
    - time to first subsequent therapy or death (TFST),
    - time to second subsequent therapy or death (TSST) and
    - time to olaparib discontinuation or death (TDT).
    To assess and describe the following for patients with BRCAm ovarian cancer and patients with sBRCAm ovarian cancer.
    - quality of life (QoL) - patterns of
    routine clinical use of olaparib, the nature and patterns of AEs of nausea and vomiting and their impact on QoL
    - safety and tolerability of olaparib maintenance monotherapy
    To describe nausea/vomiting toxicity management patterns used in routine clinical practice.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Age 18 years or over
    3. Documented germline or somatic mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). [Genetic counselling for patients with germline BRCA mutations should be performed according to local regulations] or Tumour BRCAwt status and documented qualifying mutation in any of 13 genes involved in the HRR pathway, excluding BRCA1 and BRCA2 (ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D,
    and RAD54L), identified by the Lynparza HRR Assay in archival tumour tissue (i.e., BRCA-independent HRRm)
    4. Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer)
    Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy
    5. Patients should have received at least 2 previous lines of platinum containing therapy prior to enrolment:
    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) and no evidence of a rising CA-125, following completion of this chemotherapy course.
    6. Patients must have normal organ and bone marrow function measured within 28 days of enrolment, as defined below:
    Haemoglobin ≥ 10.0 g/dL with no blood transfusions in the past 28 days
    Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    Platelet count ≥ 100 x 109/L
    7. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5x ULN
    8. Creatinine clearance > 50 ml/min (calculated)
    9. Patients must be postmenopausal or have evidence of non-childbearing status for women of childbearing potential as defined in the protocol.
    E.4Principal exclusion criteria
    1. Patients previously diagnosed with gBRCAm disease
    2. Participation in another clinical study with an investigational product during the most recent chemotherapy course
    3. Patients with a known hypersensitivity to olaparib or any of the excipients of the product
    4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to olaparib treatment. Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
    5. Persistent toxicities Common Terminology Criteria for Adverse Event (CTCAE) grade 2 caused by previous cancer therapy, excluding alopecia
    6. Patients with myelodysplastic syndrome/acute myeloid leukaemia
    7. Immuno-compromised patients e.g. Human Immunodeficiency Virus (HIV) requiring treatment or active Hepatitis B or C
    8. 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 for 28 days
    9. Patients considered to be at a high medical risk due to a serious, uncontrolled medical disorder, systemic disease or active, uncontrolled infection.
    10. Currently pregnant (confirmed with a positive pregnancy test) or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    PFS (Progression Free Survival) is defined as the time from enrolment until the date of objective radiological disease progression (assessed via RECIST 1.1) or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable efficacy assessment. However, if the patient progresses or dies after two or more missed visits, the patient will be censored at the time of the latest evaluable assessment. Given the scheduled visit assessment scheme, two missing visits will equate to more than 26 weeks since the previous RECIST 1.1 assessment, allowing for early and late visits. If the patient has no evaluable visits or does not have a baseline assessment they will be censored at day 1 unless they die within two visits of baseline (25 weeks allowing for visit window).
    The PFS time will always be derived based on scan/assessment dates not visit dates. Assessments/scans contributing towards a particular visit may be performed on different dates. The following rules will be applied:
    • Date of progression will be determined based on the earliest of the assessment/scan dates of the component that triggered the progression.
    • When censoring a patient for PFS the patient will be censored at the latest of the assessment/scan dates contributing to a particular overall visit assessment.

    Overall visit assessments will be determined for each assessment (scheduled or unscheduled) and will contribute to the derivation of PFS.

    Objective radiological progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) and an absolute increase of > 5 mm, or an overall non-target lesion assessment of progression or a new lesion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of progression
    E.5.2Secondary end point(s)
    Overall Survival (OS)
    Overall survival is defined as the time from the date of enrolment in the study until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
    Time from enrolment to second progression (PFS2)
    Time from enrolment to second progression is defined as the time from the date of enrolment to the earliest of the progression event subsequent to that used for the primary variable PFS or death. The date of second progression will be recorded by the investigator and defined according to local standard clinical practice and may involve any of objective radiological, symptomatic, CA-125 progression or death. Second progression status will be reviewed every 12 weeks following the progression event used for the primary variable PFS (the first progression) and status recorded. Patients alive and for whom a second disease progression has not been observed should be censored at the last time known to be alive and without a second disease progression, i.e. censored at the last assessment for progression date if the patient has not had a second progression or death).
    Time to first subsequent anti-cancer therapy or death (TFST)
    As a supportive summary to PFS, time to start of first subsequent anti-cancer therapy or death will be assessed. Time to first subsequent therapy or death is defined as the time from the date of enrolment to the earlier of first subsequent therapy start date, or death date. Any patient not known to have had a further subsequent therapy or death will be censored at the last known time to have not received subsequent anti-cancer therapy.
    Time to study treatment discontinuation or death (TDT)
    Time to study treatment discontinuation or death (TDT) will be assessed. TDT is defined as the time from the date of enrolment to the earlier of the date of study treatment discontinuation or death. Any patient not known to have died at the time of analysis and not known to have discontinued study treatment will be censored based on the last recorded date on which the patient was known to be alive.
    Time to second subsequent chemotherapy or death (TSST)
    As a supportive summary to PFS2, time to start of second subsequent chemotherapy or death will be assessed. Time to second subsequent chemotherapy or death is defined as the time from the date of enrolment to the earlier of the date of second subsequent chemotherapy start date, or death date. Any patient not known to have had a further second subsequent therapy or death will be censored at the last known time to have not received second subsequent chemotherapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival, TFST, TDT and TSST will be assessed from date of enrolment until the specific event or death.

    Time from randomisation to second progression (PFS2) will be assessed every 12 weeks
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Potential exploratory research into frequency, nature and predictive value of BRCA1, BRCA2 and HRR gene mutations
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Czech Republic
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 138
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 275
    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)
    After the end of the study, patients still on study therapy at that time will continue to receive olaparib outside the study until they continue to derive clinical benefit from treatment in the view of the investigator and no other criteria for treatment discontinuation are met.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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