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    Summary
    EudraCT Number:2008-003439-18
    Sponsor's Protocol Code Number:D0810C00019
    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:2008-07-31
    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 number2008-003439-18
    A.3Full title of the trial
    Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer
    A.4.1Sponsor's protocol code numberD0810C00019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00753545
    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-mailinformation.centre@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.2.1.1.1Trade name Lynparza
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameAZD2281 (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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    platinum sensitive serous ovarian cancer
    E.1.1.1Medical condition in easily understood language
    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 18.1
    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 determine the efficacy (assessed by Progression Free Survival [PFS]) of AZD2281 compared to placebo in the overall population.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    · To determine the efficacy of AZD2281 compared to placebo by assessment of overall survival (OS), best overall response, duration of response, Cancer Antigen (CA)-125 response (Gynecologic Cancer InterGroup [GCIG] criteria), time to progression by CA-125 (GCIG criteria), or RECIST.
    · · To determine the safety and tolerability of AZD2281 compared to placebo.
    · To determine the effects of AZD2281 compared to placebo on disease related symptoms.
    · To determine the quality of life of patients treated with AZD2281 compared to placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -Pharmacogenetic Analaysis: Included in the main protocol.
    Objectives: To obtain blood samples for DNA extraction for future analyses that will explore genetic factors that may influence the ADME, efficacy, safety and tolerability of AZD2281.
    -Biomarker Analysis: Included in the main protocol.
    Objectives: Determine whether there is a difference in outcome between patients whose tumours are categorised as biomarker positive or negative.
    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. Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer with a histology type of serous, or a serous component (including primary peritoneal and fallopian tube cancer). This includes patients who have developed recurrent ovarian cancer with macroscopic peritoneal metastases outside the pelvis or distant metastases. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
    4. Patients must have completed at least 2 previous courses of platinum containing therapy (e.g. carboplatin or cisplatin):
    b. For the penultimate platinum based chemotherapy course prior to enrolment on the study:
    - A patient must have been defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy.
    b. For the last chemotherapy course prior to enrolment on the study:
    - Patients must have received a platinum containing regimen.
    - Patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained to permit entry into the study.
    • This response can be confirmed as per RECIST, (note the assessment does not need to be confirmed >4 weeks later) and/or a CA-125 GCIG confirmed response (at least a 50% reduction in CA-125 levels from the last pre-treatment sample, confirmed 28 days later).
    - Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
    - Chemotherapy course must have consisted of a minimum of 4 treatment cycles.
    Note: The two platinum regimens determining eligibility do not necessarily have to be sequential. For example if a patient received topotecan between the penultimate and last platinum based chemotherapy they could be eligible provided the criteria specified above are satisfied.
    5. Formalin fixed, paraffin embedded tumour sample from the primary or recurrent 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.
    6. Pre-treatment CA-125 measurements must meet criterion specified below:
    - If the 1st value is within ULN the patient is eligible to enter the study and a second sample is not required
    - If the 1st value is greater than ULN a second assessment must be performed at least 7 days after the 1st. If the second assessment is ≥ 15% more than the first the patient is not eligible
    7. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
    - Haemoglobin ≥ 9.0 g/dL
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - White blood cells (WBC) > 3x109/L
    - Platelet count ≥ 100 x 109/L
    - Total bilirubin ≤ 1.5 x institutional upper limit of normal
    - AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
    - Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    8. ECOG performance status ≤ 2 (see Appendix F)
    9. Patients must have a life expectancy ≥ 16 weeks.
    10. Evidence of non-childbearing status: negative urine or serum pregnancy test within 28 days of study treatment for women of childbearing potential, or postmenopausal status
    Postmenopausal is defined by any one of the following:
    § natural menopause with last menses >1 year ago;
    § radiation-induced oophorectomy with last menses >1 year ago,
    § chemotherapy-induced menopause with >1 year interval since last menses,
    § serum follicle stimulating hormone, lutenising hormone and plasma oestradiol levels in the post menopausal range for the institution,
    § or surgical sterilisation (bilateral oophorectomy or hysterectomy).
    11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
    For inclusion in genetic research, patients must fulfil the following criterion:
    1. Provision of informed consent for genetic research
    If a patient declines to participate in the genetic 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 described in this Clinical Study Protocol, so long as they consent to that part.
    E.4Principal exclusion criteria
    1. Patients with low grade ovarian carcinoma. (Grade 1)
    2. Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
    3. Previous treatment with PARP inhibitors including AZD2281.
    4. 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.
    5. Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). Patients may continue the use of corticosteroids, provided the dose is stable during the study and has been started at least 4 weeks prior to enrolment.
    6. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required.
    7. Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
    8. 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.
    9. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication (eg, partial bowel obstruction or malabsorption).
    10. Patients requiring treatment with potent inhibitors or inducers of CYP3A4 (see Section 6.4.1 for guidelines and wash out periods).
    11. Pregnant or breast feeding women.
    12. Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    13. Patients with known hepatic disease (ie, Hepatitis B or C).
    14. Persistent toxicities (grade 2 or greater) caused by previous cancer therapy (excluding alopecia).
    15. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    16. Previous randomisation to treatment in the present study.
    17. Treatment with any investigational product during the last 28 days (or a longer period depending on the defined characteristics of the agents used).
    18. Patients with a known hypersensitivity to AZD2281 or any of the excipients of the product.
    19. Patients currently experiencing seizures or who were currently being treated with only anti-epileptics for seizures (use of anti-epileptic drugs to control pain is allowed in patients not suffering from seizures unless drug is excluded due to CYP3A4 induction - phenytoin, carbamazepine, phenobarbitone, see Section 6.4.1.
    20. Optional pharmacogenetics sample only:
    · previous allogeneic bone marrow transplant
    · blood transfusion in the last 120 days prior to entry to the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable
    - PFS as evaluated by RECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    137 progression events (primary analysis)
    E.5.2Secondary end point(s)
    Secondary outcome variables
    - Efficacy: OS, best overall response, duration of response, CA-125 response (GCIG criteria), time to progression by CA-125 (GCIG criteria) or RECIST, Quality of Life (QoL) and disease related symptoms.
    - Safety: AEs, physical examination, vital signs including BP, pulse, ECG and laboratory findings including clinical chemistry, haematology and urinalysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final anlaysis of OS is scheduled to take place when there are a similar number of OS events as PFS events in the primary analysis. All other efficacy secondary andpoints at primary analysis. Safety secondary endpoints at primary and final 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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Israel
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    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 entire study is defined as the date of the last visit of the last patient, occurring when all patients have completed study therapy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 250
    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 or matching placebo 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 Decision2008-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-12
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