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    Summary
    EudraCT Number:2018-002011-10
    Sponsor's Protocol Code Number:D081SC00001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-12
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-002011-10
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer
    Randomizované, dvojito-zaslepené, placebom kontrolované, multicentrické klinické skúšanie vo fáze III na porovnanie liečby olaparibom + abiraterónom oproti placebu + abiraterónu v prvej línii u mužov s metastatickým kastračne rezistentným karcinómom prostaty.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on Olaparib Plus Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer
    Štúdia s Olaparibom v kombinácii s Abiraterónom ako prvolíniovej liečby u mužov s metastatickým kastračne rezistentným karcinómom prostaty.
    A.4.1Sponsor's protocol code numberD081SC00001
    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.1.3.4CountrySweden
    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.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.com
    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 100 mg film coated Tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    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 100mg
    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.3.8 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
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 150 mg film coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    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 150 mg
    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.3.8 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
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic castration-resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate 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 determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone
    by investigator assessment of rPFS in patients with mCRPC who have received no prior cytotoxic chemotherapy or NHA at mCRPC stage.
    E.2.2Secondary objectives of the trial
    To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone as assessed by time to start of first subsequent anticancer therapy or death (TFST), time to pain progression (TTPP), and OS
    To further evaluate the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of time to opiate use, time to an SSRE, CTC conversion, and PFS2
    To assess the effect of the combination of olaparib and abiraterone vs placebo and abiraterone on disease related symptoms and HRQoL using BPI-SF and Functional Assessment of Cancer Therapy (FACT) - Prostate Cancer (FACT-P)
    To evaluate tumour and blood samples for mutations in BRCA1, BRCA2, ATM and 12 other HRR genes.
    To determine steady-state exposure to abiraterone and its active metabolite Δ4-abiraterone in the presence and absence of olaparib.
    To evaluate the safety and tolerability of the combination of olaparib and abiraterone vs placebo
    and abiraterone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
    2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
    3. 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 prior to collection of sample.
    - Provision of informed consent for biomarker research prior to collection of sample.
    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.
    4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative.
    5. Histologically or cytologically confirmed prostate adenocarcinoma.
    6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a CT/MRI scan.
    7. First-line mCRPC.
    8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 ng/dL (<2.0 nmol/L) within 28 days before randomisation. Patients receiving ADT at study entry should continue to do so throughout the study.
    9. Candidate for abiraterone therapy with documented evidence of progressive disease.
    10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
    11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see Appendix B), with no deterioration over the previous 2 weeks.
    12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
    13. Prior to randomisation, sites must confirm availability of either an archival FFPE tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable HRR status subgroup analysis of the primary endpoint rPFS. If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study.
    14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see Appendix I for acceptable methods) if they are of childbearing potential.
    E.4Principal exclusion criteria
    1. Has a known additional malignancy that has had progression or has required active
    treatment in the last 5 years.
    2. Patients with MDS/AML or with features suggestive of MDS/AML.
    3. Clinically significant cardiovascular disease
    Association Class II-IV heart failure or cardiac ejection fraction measurement of <50%
    during screening as assessed by echocardiography or multigated acquisition scan.
    4 Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
    5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery
    stenosis).
    6. Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg).
    7. History of uncontrolled pituitary or adrenal dysfunction.
    8. Active infection or other medical condition that would make prednisone/prednisolone use
    contraindicated.
    9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 mg
    prednisone/prednisolone per day.
    10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical
    disorder, non-malignant systemic disease or active, uncontrolled infection.
    11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade
    >2) caused by previous cancer therapy, excluding alopecia.
    12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not
    required.
    13. Patients with spinal cord compression are excluded unless they are considered to have
    received definitive treatment for this and have evidence of clinically stable disease for
    4 weeks.
    14. Patients who are unevaluable for both bone and soft tissue progression
    15. Patients who are unable to swallow orally administered medication and patients with
    gastrointestinal disorders likely to interfere with absorption of the study medication.
    16. Immunocompromised patients
    17. Patients with known active hepatitis infection (ie, hepatitis B or C).
    18. Any previous treatment with PARP inhibitor, including olaparib.
    19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.
    20. Any previous exposure to a CYP17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).
    21. 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 study treatment is 2 weeks.
    22. Concomitant use of known strong CYP3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John’s wort) or moderate CYP3A inducers (eg, bosentan, efavirenz or modafinil). The required
    period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents.
    23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
    (dUCBT).
    25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.
    26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone.
    27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).
    28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
    29. Previous randomisation in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Radiological progression free survival (rPFS) - defined as the time from randomisation to
    1) radiographic progression, assessed by investigator per RECIST 1.1 (soft tissue) and PCWG-3 criteria (bone), or
    2) death from any cause, whichever occurs first
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and every 8 weeks (± 7 days) until week 24 and every 12 weeks (± 7 days) thereafter, relative to the date of randomisation, until objective radiological disease progression is confirmed by the investigator.
    E.5.2Secondary end point(s)
    1. Time to first subsequent anticancer therapy or death (TFST)

    2. Time to pain progression (TTPP)

    3. Overall survival (OS)

    4. Time to opiate use

    5. Time to an SSRE

    6. Proportion of patients who achieve a decline in the number of CTCs from ≥5 cells/7.5 mL at baseline to <5 cells/7.5 mL at any time post baseline in whole blood (CTC conversion rate).

    7. PFS2

    8. BPI-SF: progression in pain severity domain, change in pain interference domain, and pain palliation.

    9. FACT-P total score, FACT-G total score, trial outcome index, functional well-being, physical
    well-being, prostate cancer subscale, and FACT Advanced Prostate Symptom Index-6 (FAPSI-6).

    10. HRR gene status

    11. Plasma concentration data at steady state for olaparib, abiraterone, and Δ4-abiraterone in the subset of patients evaluable for PK.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time from randomisation to the earlier of the first subsequent anticancer therapy start date following study treatment discontinuation or death from any cause.

    2. Time from randomisation to pain progression

    3. Time from randomisation to death from any cause.

    4. Time from randomisation to the first opiate use for cancer-related pain.

    5. Time from randomisation to the first SSRE.

    6. From baseline to at any time post baseline.

    7. Time from randomisation to second progression or clinical progression or death.

    8. Subjects will complete the BPI-SF daily on the ePRO device for 7 days just prior to day 1 baseline visit and every 4 weeks.

    9. Every 4 weeks (starting on Day 1) in the first year and every 8 weeks thereafter.

    10. At baseline

    11. Visit 4
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Australia
    Belgium
    Brazil
    Canada
    Chile
    China
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Slovakia
    Spain
    Turkey
    United Kingdom
    United States
    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
    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 years4
    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 years4
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    F.2 Gender
    F.2.1Female No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 720
    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 end of treatment with study drug, patients should be managed according to local standard of care.
    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 Decision2018-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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