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    Summary
    EudraCT Number:2015-005838-22
    Sponsor's Protocol Code Number:CLIO
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-10
    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 number2015-005838-22
    A.3Full title of the trial
    Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovarian cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovarian cancer
    A.3.2Name or abbreviated title of the trial where available
    CLIO
    A.4.1Sponsor's protocol code numberCLIO
    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 SponsorUZLeuven
    B.1.3.4CountryBelgium
    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 supportUZLeuven
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportAstra Zeneca
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZLeuven
    B.5.2Functional name of contact pointJoke De Roover
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216347419
    B.5.5Fax number3216347687
    B.5.6E-mailjoke.deroover@uzleuven.be
    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 holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.8INN - Proposed INNolaparib
    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 typeup to
    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
    platinum-sensitive and platinum-resistant relapsed ovarian cancer
    E.1.1.1Medical condition in easily understood language
    patient with ovarian cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the value of a ctDNA-based assay for homologous recombination deficiency to predict response to olaparib monotherapy. This analysis will also be performed according to platinum-sensitivity (platinum-sensitive versus platinum-resistant).
    E.2.2Secondary objectives of the trial
    -Demonstrate the value of a ctDNA-based assay for homologous recombination deficiency to predict duration of response, disease control rate, progression-free survival and overall survival to olaparib monotherapy. These analyses will also be performed according to platinum-sensitivity (platinum-sensitive versus platinum-resistant).
    -Demonstrate the value of a tissue DNA-based assay (fresh frozen/FFPE) for homologous recombination deficiency to predict response, progression-free survival, duration of response and overall survival to olaparib monotherapy.
    -Assess the efficacy of olaparib monotherapy versus phycician’s choice chemotherapy after randomization in the study with regards to response, duration of response, progression-free survival and overall survival in patients with both a platinum-sensitive and a platinum-resistant relapse. The study is powered for subgroup analyses on these 2 cohorts.
    -Assessment of Quality of Life for all enrolled subjects
    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 with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum with following histology (rationale for inclusion beyond high-grade serous: see Pennington et al. 2014):
     Serous (high grade = grade 2 or 3)
     Endometrioid (all grades)
     Clear-cell (all grades)
     Carcinosarcoma
     Undifferentiated carcinoma

    3.Female patients (≥ 18 years) with platinum sensitive relapsed ovarian cancer (PSOC), excluding known deleterious germline or somatic BRCA1/2 mutations, OR
    Platinum resistant relapsed ovarian cancer (PROC), including cases with known deleterious BRCA1/2 germline or somatic mutations.

    4.At least 1 previous line of chemotherapy

    5.Patients must have measurable disease on imaging according to RECIST criteria 1.1

    6.Archival tissue of the primary tumor available (either fresh-frozen or FFPE)

    7.Patients consent for a biopsy of the relapsed tumor at the start of treatment and at disease progression. A failure to obtain these samples (due to technical or safety reasons) does however not exclude patients from the study.

    8.Patient consent to germline BRCA1/2 testing.

    9.Patients have a normal organ and bone marrow function measured within 28 days of randomization, as defined below:
    a.Hemoglobin ≥ 10.0 g/dL with no blood transfusions in the past 28 days
    b.Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    c.Platelet count ≥ 100 x 109/L
    d.Total bilirubin ≤ 1.5 x institutional upper limit of normal
    e.Aspartate aminotransferase (AST) (SGOT) / Alanine aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
    f.Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)

    10.Previous treatment with a PARP-inhibitor is allowed.

    11.Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    12.Patients must have a life expectancy ≥ 16 weeks

    13.Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1
    E.4Principal exclusion criteria
    1.Involvement in the planning and/or conduct of the study
    2.Previous randomisation in the present study
    3.Patients with primary platinum-refractory disease (i.e. platinum refractory during or after first line of chemotherapy).
    4.Patients with a known hypersensitivity to olaparib or any of the excipients of the product
    5.Patients with a known hypersensitivity to comparator agent
    6.Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
    7.Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib treatment. Target lesion should be outside radiated field.
    8.Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
    9.Patients with myelodysplastic syndrome/acute myeloid leukaemia
    10.Immunocompromised patients (e.g. HIV) requiring treatment or active Hepatitis B or C
    11.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
    12.Major surgery within 2 weeks of starting study treatment. Furthermore, patients must have recovered from any effects of any major surgery.
    13.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, 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
    14.Patients with uncontrolled seizures.
    15.Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
    16.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
    17.Pregnant or breast feeding women
    E.5 End points
    E.5.1Primary end point(s)
    OOR (overall objective response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary ctDNA-based genomic classifier
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q3 2018
    E.5.2Secondary end point(s)
    -DOR (duration of response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary ctDNA-based genomic classifier

    -DCR (disease control rate) at 12 weeks and later by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary ctDNA-based genomic classifier

    -PFS (progression-free survival) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary ctDNA-based genomic classifier

    -OS (overall survival) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary ctDNA-based genomic classifier

    -OOR (overall objective response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary tissue DNA-based genomic classifier

    -DOR (duration of response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary tissue DNA-based genomic classifier

    -DCR (disease control rate) at 12 weeks and later by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary tissue DNA-based genomic classifier

    -PFS (progression-free survival) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary tissue DNA-based genomic classifier

    -OS (overall survival) in patients receiving olaparib monotherapy, stratified for HR-deficiency as defined by a binary tissue DNA-based genomic classifier

    -OOR (overall objective response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy vs physician’s choice chemotherapy after randomization in the study

    -DOR (overall objective response) by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy vs physician’s choice chemotherapy after randomization in the study

    -DCR (disease control rate) at 12 weeks and later by modified RECIST v1.1 (Eisenhauer et al. 2009) in patients receiving olaparib monotherapy vs physician’s choice chemotherapy after randomization in the study

    -PFS (progression-free survival) in patients receiving olaparib monotherapy vs physician’s choice chemotherapy after randomization in the study

    -OS (overall survival) in patients receiving olaparib monotherapy vs physician’s choice chemotherapy after randomization in the study

    -Assess quality of life (QoL) for all enrolled subjects as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ-C30) and the EORTC QLQ-Ovarian cancer module (QLQ-OV28).

    E.5.2.1Timepoint(s) of evaluation of this end point
    Q2 2019
    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 No
    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 Yes
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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
    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 Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-09
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