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    Summary
    EudraCT Number:2009-015970-36
    Sponsor's Protocol Code Number:D0810C00041
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-14
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-015970-36
    A.3Full title of the trial
    A Phase II, Open-Label, Randomised, Comparative, Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination with Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients with Platinum Sensitive Advanced Serous Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib in combination with carboplatin and paclitaxel in patients with advanced ovarian cancer
    A.4.1Sponsor's protocol code numberD0810C00041
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01081951
    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
    B.5.2Functional name of contact pointInformation Centre
    B.5.6E-mailinformationcenter@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 No
    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/3/07/501
    D.3 Description of the IMP
    D.3.1Product nameolaparib
    D.3.2Product code AZD2281, KU-0059436
    D.3.4Pharmaceutical form Capsule
    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 (KU-0059436)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Serous ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Advanced ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of oral olaparib in combination with carboplatin and paclitaxel versus carboplatin and paclitaxel alone, by assessment of Progression Free Survival (PFS). (Independent Central Review)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:
    - To compare the efficacy of olaparib when given in combination with paclitaxel and carboplatin to paclitaxel and carboplatin alone, by assessment of Overall Survival (OS), percent change in tumour size, Objective Response Rate (ORR), Ovarian Cancer Response Rate (a composite of CA-125 Response Rate [Gynecologic Cancer InterGroup {GCIG} criteria] and/or RECIST Response Rate), and CA-125 response rate (GCIG criteria).

    - To compare the safety and tolerability of olaparib when given in combination with paclitaxel and carboplatin to paclitaxel and carboplatin alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of fully informed consent prior to any study specific procedures
    2. Patients must be > 18 years of age.
    3. Histologically or cytologically diagnosed ovarian cancer with a serous histology or a serous component, including primary peritoneal and fallopian tube cancer.
    4. Patients who have received no more than 3 previous platinum containing regimens and were progression free, in the opinion of the Investigator, for a minimum of 6 months following completion of their last platinum containing regimen, prior to randomisation in the study.
    5. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
    6. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
    7. ECOG performance status ≤ 2
    8. Patients must have a life expectancy ≥ 12 weeks.
    9. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.
    10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.


    E.4Principal exclusion criteria
    1. Patients receiving any systemic anticancer chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
    2. Patients with second primary cancer, 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.
    3. 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.
    4. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
    5. Patients with severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients in paclitaxel.
    6. Patients with a known hypersensitivity to olaparib or any of the excipients of the products
    7. Patients with a history of severe allergic reaction to carboplatin or other platinum containing compounds. Patients who require desensitisation procedures for further platinum-based treatment should not be included.
    8. Hypersensitivity to pre-medications required for treatment with carboplatin / paclitaxel.
    9. Any previous treatment with a PARP inhibitor, including olaparib.
    10. Patients receiving inhibitors of CYP3A4.
    11. Persisting toxicities (>CTCAE grade 2) caused by previous cancer therapy.
    12. 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, or any psychiatric disorder that prohibits obtaining informed consent.
    13. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    14. Breast feeding women.
    15. known immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    16. Patients with known active hepatic disease (i.e., Hepatitis B or C).
    17. Patients with uncontrolled seizures.
    18. Previous randomisation in this study.
    19. Participation in another clinical study with an investigational product during the last 14 days.
    20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)




    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable:
    Progression Free Survival (PFS) based on Central Review





    E.5.1.1Timepoint(s) of evaluation of this end point
    38 progression events (interim 2)
    70 progression events (primary analysis)
    90 progression events (post-primary analysis)
    E.5.2Secondary end point(s)
    · Secondary outcome variables:
    - Overall Survival (OS)
    - Percentage change in tumour size
    - Objective response rate
    - Ovarian Cancer Response Rate
    - CA 125 response (Gynaecologic Cancer InterGroup [GCIG] criteria)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Overall Survival (OS): at 90 deaths (final OS analysis). An interim analysis will be performed when at least 30% deaths have occurred. If there is insufficient evidence of an effect on OS at the time of the interim analysis, then a decision may be made not to continue to the planned final OS analysis at 60% OS maturity (approximately 90 deaths)

    - Percentage change in tumour size: baseline and after 9 weeks for first 50 patients (interim 1)

    - Objective response rate: interim 1, interim 2, primary analysis, and post-primary analysis

    - Ovarian Cancer Response Rate: interim 1, interim 2, primary analysis, and post-primary analysis

    - CA 125 response: interim 1, interim 2, primary analysis, and post-primary analysis



    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 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 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 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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    Czech Republic
    Germany
    Italy
    Japan
    Netherlands
    Panama
    Spain
    United Kingdom
    United States
    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
    The end of this study is defined as the date of the last visit of the last patient, occurring when all patients have completed study therapy. There will be a final data cut-off defined as the time when all patients receiving olaparib or placebo have been followed for a minimum period of 6 months since start of treatment or the date of the final analysis of the data, whichever is the later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 150
    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)
    Once patients receiving AZD2281 have been discontinued from study treatment, other treatment options will be at the discretion of the investigator.
    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 Decision2010-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
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