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    Summary
    EudraCT Number:2018-002966-37
    Sponsor's Protocol Code Number:1-2018BSMO
    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:2019-03-06
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002966-37
    A.3Full title of the trial
    Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    an open explorative phase II, open label study of olaparib in the treatment of advanced cancer in patients carrying a somatic or germline mutation in a homologous recombination gene.
    A.3.2Name or abbreviated title of the trial where available
    Precision 2 - Olaparib
    A.4.1Sponsor's protocol code number1-2018BSMO
    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 SponsorBelgian Society of Medical Oncology
    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 supportBSMO
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointDr. Sofie Joris
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityBrussel
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3224776415
    B.5.6E-mailsofie.joris@uzbrussel.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 Olaparib
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Advanced cancer patients that have a germline mutation or a somatic mutation in their tumor. Prostate and ovarian cancer patients and breast cancer patients who carry a BRCA1/2 mutation will be excluded because there are ongoing or planned sponsored international trials running in these cohorts. All other cancer types with a homologous recombination deficiency will be eligible as well as breast cancers with non-BRCA1/2.
    E.1.1.1Medical condition in easily understood language
    Advanced cancer patients that have a germline mutation or a somatic mutation in their tumor. All cancer types with a homologous recombination deficiency will be eligible.
    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
    Primary: document anti-tumor activity (measured by response rate and response duration) of olaparib in advanced cancer patients that have a germline mutation or a somatic tumor mutation among a defined list of HR genes: BRCA1/2, ATM, BARD1, BRIP1, CHEK1, CHEK2, MRE11A, NBN, PALB2, RAD50, RAD 51B, RAD51C, RAD51D, RAD54L, FAM175A, CDK12, FANCL, p53 (only germline) and PPP2R2A. This is the minimal list of genes when mutated causing an HRD currently included in the routine genetic panel testing in the Belgian genetics labs. Other gene mutations proven to cause HRD are also eligible pending approval by the PI.
    E.2.2Secondary objectives of the trial
    Secondary: correlate efficacy with locus-specific LOH in the tumors in case of cancers not routinely associated with the germline mutations (optional and separate informed consents for participants). Although the presence of LOH is not an absolute marker of the relevance of the mutation in a particular cancer, it gives a strong probability against which the response data can be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Provision of informed consent prior to any study specific procedures
    2- Female or male aged > 18 years
    3- Histologically proven advanced cancer, either locally or metastatic, harboring a specific pathogenic genetic alteration (with the exception of breast, pancreas, ovarian or prostate cancer patients harboring a BRCA1/2 mutation)
    4- No approved targeted therapy for the specific genetic alteration in the specific tumor type
    5- No other genomic driven phase I, II or III trial available for the specific genomic alteration in the specific tumor type
    6- Available tumor tissue for verification of the mutation by Sanger sequencing.
    7- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
    8- Eastern Cooperative Oncology Group (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- Patients are 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 by CT and is suitable for repeated assessment.
    13- *Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer must be available for central testing.
    14- For patients not entering the trial after identification of a genetic alteration in the Precision 1 trial, 2 samples of 10 ml EDTA tubes should be taken to make germ-line DNA analysis possible.
    15- A new biopsy of tumor tissue with consent of the patient at the moment of progressive disease is preferable
    E.4Principal 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- Ovarian cancer patients harboring a HRD and breast, prostate and pancreas cancer patients who carry a BRCA1/2 mutation
    3- Previous enrolment in the present study
    4- Participation in another clinical study with an investigational product during the last 4 weeks or radiotherapy (except for palliative reasons) within three weeks prior to study treatment.
    5- History of non-compliance to medical regimens
    6- Any previous treatment with PARP inhibitor, including olaparib.
    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. Patients with a history of localized 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
    8- Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or indicating uncontrolled, potentially reversible cardiac conditions as judged by the investigator (er., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500ms, electrolyte disturbances, etc.) or patients with congenital long QT syndrome
    9- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within four weeks prior to study treatment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
    10- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir orcobicistat, 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.
    11- 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.
    12- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia
    13- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
    14- 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.
    15- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    16- 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.
    17- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    18- Breast feeding women. (delete if male population)
    19- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    20- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    21- Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
    22- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
    23- 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.3)
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    1) Response rate according to RECIST 1.1
    2) Response duration
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) and 2) every 8 weeks until cycle 7 thereafter every 12 weeks
    E.5.2Secondary end point(s)
    Secondary:
    1) Correlate efficacy with locus-specific LOH in the tumors in case of cancers atypical for the germline mutations.
    2) PFS
    3) OS
    4) Safety by reporting all adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) every 8 weeks until cycle 7 thereafter every 12 weeks
    2) and 3) every 3 months
    4) every 4 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 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 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) 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 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 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
    Last visit of the last subject
    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: 342
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 171
    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 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 state513
    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 Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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