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    Summary
    EudraCT Number:2018-002584-25
    Sponsor's Protocol Code Number:69HCL18_0132
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002584-25
    A.3Full title of the trial
    A phase II study of olaparib in recurrent IDH mutated high grade gliomas
    OLAGLI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of olaparib in recurrent IDH mutated high grade gliomas
    OLAGLI
    A.3.2Name or abbreviated title of the trial where available
    OLAGLI
    A.4.1Sponsor's protocol code number69HCL18_0132
    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 SponsorHOSPICES CIVILS DE LYON
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPICES CIVILS DE LYON
    B.5.2Functional name of contact pointZUBLENA
    B.5.3 Address:
    B.5.3.1Street Address3 Quai des Celestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number04 72 40 68 46
    B.5.5Fax number04 72 11 51 90
    B.5.6E-maildrci_promo@chu-lyon.fr
    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 LYNPARZA
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOLAPARIB
    D.3.4Pharmaceutical form 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.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    patients with recurrent IDHm HGGs.
    E.1.1.1Medical condition in easily understood language
    patients with recurrent IDHm HGGs.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    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 evaluate the efficacy of olaparib, based on 6 months progression-free survival (PFS6) as assessed by RANO criteria, in patients with recurrent IDHm HGGs.
    E.2.2Secondary objectives of the trial
    • To evaluate median progression-free survival (median-PFS) assessed by RANO criteria
    • To evaluate overall survival (OS) assessed by RANO criteria
    • To evaluate overall response rate (ORR) assessed by RANO criteria
    • To evaluate duration of response assessed by RANO criteria
    • To evaluate longitudinal changes in quality of life (EORTC QLQ-C30 and BN20)
    • To evaluate the safety and tolerability of olaparib in patients with recurrent IDHm HGGs

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    21. Affiliation to a French social security system (recipient or assign) excluding AME.
    22. Histological confirmation of grade III or IV high-grade glioma or evidence of anaplastic transformation (based on histological or radiological analysis) of a previous grade II glioma
    23. Tumor is mutated for IDH1 or IDH2 gene (detected by R132HIDH immunochemistry or IDH1/IDH2 sequencing)
    24. Recurrence after radiotherapy and at least one line of alkylating chemotherapy (Temozolomide or PCV (Procarbazine, CCNU, Vincristine) (Surgery at recurrence is allowed before trial inclusion)
    25. Recurrence occurring more than 12 weeks from the end of the radiotherapy or occurring outside the irradiated volume
    26. Provision of informed consent prior to any study specific procedures
    27. Age ≥ 18 years old
    28. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment 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 institutional upper limit of normal
     Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test :
    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 and F=1 for males.

    29. KPS ≥ 70
    30. Patients must have a life expectancy ≥ 16 weeks.
    31. 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:
     Amenorrheic for 1 year or more 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)

    32. Female patients of child bearing potential and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two highly effective forms of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 1 month (female patients)/3 months (male patients) after last dose of study drug
    33. Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
    34. Except in patients who undergo re-surgery, radiologically measurable disease based on RANO criteria, i. e . at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by MRI and is suitable for repeated assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    35. Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer must be available for central testing. If there is not written confirmation of the availability of an archived tumour sample prior to enrolment the patient is not eligible for the study.
    36. For inclusion in the optional biomarker research, patients must fulfil the following criteria:
     Provision of informed consent for biomarker research
     If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
    E.4Principal exclusion criteria
    37. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    38. Previous enrolment in the present study
    39. Participation in another clinical study with an investigational product during the last month
    40. Any previous treatment with PARP inhibitor, including olaparib.
    41. Other malignancy unless curatively treated with no evidence of disease for ≥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. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
    42. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
    43. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
    44. 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.
    45. 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.
    46. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
    47. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
    48. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    49. 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.
    50. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    51. Breast feeding women.
    52. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    53. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    54. Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
    55. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
    56. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no.8)
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival at 6 months (24 weeks) (PFS-6) estimated by the RANO criteria.
    Progression free survival (PFS) is defined as the time from study inclusion to time of tumor progression or death due to any cause, whichever comes first. PFS-6 is the percentage of patients who have not progress 6 months after study inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    • Median-PFS is defined by the time in which fifty percent (50%) of patients have experienced tumor progression or death due to any cause or the date of last tumor assessment.
    • Overall Survival: Overall survival is defined as the time from study inclusion to death due to any cause, or to the date of censoring at the last time the subject was known to be alive in intention-to-treat populations
    • Overall response rate is defined by the percentage of patients with complete response and partial response using RANO criteria. The overall response rate will be assessed by the local investigators and after central radiological review that will be done at the end of the study.
    • Duration of response is defined by the time from confirmation of stable, partial and complete response using RANO criteria until the tumor progression has been shown.
    • Longitudinal changes in quality of life (EORTC QLQ-C30 and BN20)
    • Safety: Type, frequency and severity of adverse events and serious adverse events. The adverse events will be described and graded according to the revised NCI Common Terminology Criteria V4.03 for Adverse Events (CTCAE V4.03) at each clinical visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    LVLS
    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 months6
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    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 state35
    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)
    if at the end of the study some patients are still treated with olaparib and progression-free, the duration of the study will be extended in order to allow these patients to continue olaparib treatment which will continue to be provided by AstraZeneca.
    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 Decision2018-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-08
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