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    Summary
    EudraCT Number:2018-001660-29
    Sponsor's Protocol Code Number:FAB18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001660-29
    A.3Full title of the trial
    FAB: Functional Analysis of BRCAness
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FAB: Functional Analysis of BRCAness
    A.3.2Name or abbreviated title of the trial where available
    FAB18
    A.4.1Sponsor's protocol code numberFAB18
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportAstra Zeneca
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportKWF
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointJudith Kroep
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715263464
    B.5.6E-mailj.r.kroep@lumc.nl
    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 Olaparib
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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/0/07/501
    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.3.11 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
    Recurrent epithelial ovarian cancer
    Recifief epitheliaal ovarium carcinoom
    E.1.1.1Medical condition in easily understood language
    recurrent ovarian cancer
    recidief eierstok kanker
    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 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the outcome of the RAD51 assay (HR proficient or HR deficient according to RECAP test) correlates with objective response rate (RR according to RECIST 1.1) of olaparib, in patients with recurrent high grade epithelial ovarian cancer.
    Vaststellen of de uitkomst of de uitslag van de RAD51 assay (RECAP test) voorspelt welke patiënten met een hooggradig recidief epitheliaal ovarium carcinoom gevoelig zijn (response rate volgens RECIT 1.1) voor behandeling met PARP-remmers
    E.2.2Secondary objectives of the trial
    - Compare the descriptive 1 yr PFS of olaparib for the BRCA1 or BRCA2 mutant (germline or somatic) HR deficient group, the non BRCA mutant HR deficient group and the HR proficient group, with HR defined according to the RAD51 assay.
    - Correlation of RAD51 assay outcomes with overall survival (OS).
    - Determine percentage of informative RAD51 test results of RAD51 assay in tumor biopsies and/or ascites.
    - Compare the outcome of the RAD51 assay with the Lynparza 15-gene HRR assay.
    - Determine grade 3 / 4 toxicity.
    Exploratory:
    - Identify molecular markers (including genomic markers in tumor or ascites) that are associated with the outcome of the RAD51 assay.
    - Explore whether these molecular markers can be measured in liquid biopsies (by analysing ctDNA in blood).
    - Vergelijk 1 jaar PFS van olaparib voor de BRCA mutante groep vs non-BRCA mutante HRD groep vs HR proficiente groep.
    - Correlatie uitslag RAD51 test en totale overleving
    - Bepalen van aantal informatieve RAD51 testen
    - Vergelijking uitslag RAD51 test en Lynparza 15-genen panel
    - Bepalen van Graad 3/4 toxiciteit

    Exploratief:
    - Identificatie moleculaire markers geassocieerd met de uitkomst van de RAD51 assay.
    - ctDNA analyse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with recurrent high grade serous or endometrioid EOC (> 3 months after platinum
    containing chemotherapy and unwilling or ineligible for platinum based therapy) with a tumor
    lesion that is amendable for biopsy or who can undergo ascites drainage prior to treatment.
    treatment.
    2. Diagnosis of high grade serous or endometrioid EOC confirmed by histology .
    3. Provision of informed consent prior to any study specific procedures
    4. Female aged >18 years
    5. Patients must have normal organ and bone marrow function measured within 28 days prior to administration olaparib as defined below:
     Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
     Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
     Platelet count ≥ 100 x 109/L
     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 ULN unless liver metastases are present in which case they must be ≤ 5x ULN
     Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
    Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a
    serum creatinine (mg/dL) x 72
    a where F=0.85 for females
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    7. Patients must have a life expectancy ≥ 16 weeks.
    8. 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.
    Postmenopausal is defined as:
     Amenorrhoea for > 1 year, following cessation of exogenous hormonal treatments
     Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
     radiation-induced oophorectomy with last menses >1 year ago
     chemotherapy-induced menopause with >1 year interval since last menses
     surgical sterilisation (bilateral oophorectomy or hysterectomy)
    9. Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
    10. Evaluable disease (measurable and/or non-measurable) that can be accurately assessed at baseline using RECIST 1.1 by CT or MRI and is suitable for repeated assessment (appendix B).
    11. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfil the following criteria:
     Provision of informed consent for genetic research
     Provision of informed consent for biomarker research
    Patienten met recidief hoog gradig sereus of endometrioid EOC (> 3 maanden na platinum
    bevattende chemotherapie en niet wullen of in aanmering komend voor platinum based therapie) met de mogelijkheid voor een tumor biopsue of ascites drainage voor start behandeling
    2. Diagnose hoog gradig sereus of endometrioid EOC histologisch bewezen .
    3. Geschreven Informed Consent
    4. vrouw >/=18 jaar
    5. Normale orgaan een beenmerg functie, gemweten binnen 28 dagen voor sart olaparib, gedefinieerd als:
     Hb ≥ 10.0 g/dL , zonder bloedtransfusie de laatste 28 dagen
     Absoluut neutrofiel getal (ANC) ≥ 1.5 x 109/L
     Thrombocyten ≥ 100 x 109/L
     Total bilirubine ≤ 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 ULN tenzij lever metastasen, dan ≤ 5x ULN
     Creatinine klaring geschat mbv de Cockcroft-Gault equation of ≥51 mL/min
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    7. Levens verwachting≥ 16 weeks.
    8. Postmenopausaal or bewijs van afwezigheid van zwangerschap voor premenopausale/vruchtbare vrouwen: negatieve urine of serum zwangerschaps test binnen 28 dagen voor start studie nedicatie en voor start van behandeling op dag 1.
    Postmenopausaal is alsvolgt gedefineerd:
     Amenorrhoea > 1 year, na staken endocriene therapie
     Luteinizing hormone (LH) en Follicle stimulating hormone (FSH) waarden in de post menopausale range voor vrouwen onder 50 jaar
     radiatie-geinduceerde oophorectomy en laatste menstruatie >1 jaar
     chemotherapy-geinduceerde menopause en laatste menstriuatie >1 jaar
     chirurgische sterilisatie (bilateral oophorectomy of hysterectomy)
    9. Patients compliant willen en kunnen zijn.
    10. Evalueerbare ziekte (meetbaar en/of niet-meetbaar) als beoordeeld bij baseline middels RECIST 1.1 mbv CT of MRI.
    11. Voor inclusie in i) optioneel genetische ondezoek en ii) optioneel biomarker onderzoek, dienen patienten te voldoen aan de volgende criteria:
     Geschreven informed consent voor genetisch onderzoek
     Geschreven informed consent voor biomarker onderzoek
    E.4Principal exclusion criteria
    Participation in another clinical study with an investigational product during the last months
    13. Any previous treatment with PARP inhibitor, including olaparib.
    14. *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 breast cancer and lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥3 years.
    15. Patients receiving radiotherapy y within 3 weeks prior to study treatment.
    16. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
    17. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
    18. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) >-grade 2) caused by previous cancer therapy, excluding alopecia.
    19. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. 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.
    20. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    21. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
    22. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    23. Breast feeding women.
    24. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    25. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    26. Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
    27. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
    28. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
    29. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment.
    30. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
    Deelname in een andere studie met een onderzoeksmiddel gedurende de afgelopen maand.
    13. Eerdere behandeling met PARP remmer, inclusief olaparib.
    14. *andere maligniteit de afgelopen 5 jaar, muv: adequaat behandelde non-melanoom huidkanker, curatief behandeldein situ cancer, stadium 1 en graad 1 endometrial carcinoom, of andere solide tumoren incusief mammacarcinoom en lymfoom (zonder beenmerg betrokkenheid) curatief behendeld zonder aanwijzimg voor ziekte voor ≥3 years.
    15. Radiotherapy binnen 3 weken voor studie behandeling.
    16. Gelijktijdig gebruik van sterke CYP3A remmers (bv. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) of gemiddel sterke CYP3A remmers (bv. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). De benodigde washout periode voor start olaparib is 2 weken.
    17. Gelijktijdig gebruik vann sterke (bv. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort ) of gemiddelde CYP3A inducers (eg. bosentan, efavirenz, modafinil). De benodigde washout periode voor start olaparib 5 weken voor enzalutamide of phenobarbital en 3 weken voor de overige middelen.
    18. Persisterende toxiciteit (Common Terminology Criteria for Adverse Event (CTCAE) >-grade 2) tgv eerdere antitumor therapie, exclusief alopecia.
    19. Symptomatische ongecontroleerde hersen metastasen. stabiele dosering corticosteroiden is toegestaan indien deze minimaal 4 weken zijn gestart voor start olaparib. Patienten met spinal cord compressie tenzij ze hiervoor behandeld zijn en klinisch stabiel gedurende 28 days.
    20. Grote chirurgie binnen 2 weken en patienten dienen te zijn hersteld van elk effect van enige eerdere chirurgie.
    21. Patienten met medisch risico obv een serieus ungecontroleerde medische aandoening of infectie. Voorbeelden inclderen, maar zijn niet gelimiteerd tot, ongecontroleerde ventriculaire aritmie, recent (binnen 3 maanden) hart infarct, ongecontroleerd CVA, onstabiel of dreigende dwarslesie, vena cava superior syndroom, extensieve interstitiele long ziekte of enige psychiatrische ziekte dat het informed concent belemmert.
    22. Patienten die geen orale medicatie kunnen innemen of met een verminderde orale absorptie.
    23. patienten die borstvoeding geven.
    24. Immuun gecompromiteerde patienten.
    25. Bekende hypersensitiviteit van olaparib of bestanddelen van het product.
    26. Bekende actieve hepatitis (bv Hepatitis B of C)
    27. Eerdere allogene beenmerg of navestreng transplantatie.
    28. Bekend myelodysplastisch syndroome / acute myeloide leukaemie of kenmerken suggestief voor MDS/AML.
    29. Bloed transfusie in de afgelopen 120 dagen en trombocyten transfusie in de afgelopen 28 dagen vor start behandelng.
    30. Rust ECG met QTc > 470 msec op 2 of meer tijdspunten binnen 24 hr of familie geschiedenis met een lang QT syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    response rate according to RECIST 1.1
    outcome RAD51 test
    response rate volgens RECIST 1.1
    Uitkomst van de RAD51 test
    E.5.1.1Timepoint(s) of evaluation of this end point
    response rate according to RECIST 1.1: every 12 weeks
    outcome RAD51 test: baseline
    response rate volgens RECIST 1.1: elke 12 weken
    Uitkomst van de RAD51 test: baseline
    E.5.2Secondary end point(s)
    Overall survival
    Toxicity according to NCI-CTC v4.03 criteria
    Overleving
    Toxiciteit volgens NCI CTC v4.03 criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival: end of study
    Toxicity according to NCI-CTC v4.03 criteria: every 4 weeks
    Overleving: studie einde
    Toxiciteit volgens NCI CTC v4.03 criteria: elke 4 weken
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 concerned3
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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