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    Summary
    EudraCT Number:2007-007622-22
    Sponsor's Protocol Code Number:D0810C00012
    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:2008-05-29
    Trial results View 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 number2007-007622-22
    A.3Full title of the trial
    A Phase II Open-Label, Randomised, Comparative, International Multicentre Study to Compare the Safety and Efficacy of Two Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer Who Have Failed Previous Platinum Based Chemotherapy
    A.4.1Sponsor's protocol code numberD0810C00012
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAZD2281 (KU-0059436)
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive name4-(3-{[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2H)-one
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 BRCA1 or BRCA2 associated ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of 2 different dose levels of AZD2281 versus liposomal doxorubicin in patients with advanced BRCA1 or BRCA2 associated ovarian cancer. This will be assessed by the following:
    primary variable
    · progression free survival (PFS)
    secondary variables
    · objective response rate (complete response (CR) and partial response (PR)) at various timepoints and overall
    · overall duration of response
    · tumour size
    · CA 125 levels
    · Overall survival (OS)
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    · To compare the safety and tolerability profile of 2 different dose levels of AZD2281 versus liposomal doxorubicin in the study population.
    · To determine AZD2281 exposure at the 2 different dose levels following oral administration.
    · To conduct a preliminary assessment of Quality of Life (QoL) as measured by the Functional Assessment of Cancer Therapy – Ovarian Cancer (FACT-O) questionnaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female, aged 18 years or older.
    2. Histologically or cytologically confirmed advanced ovarian cancer, stage IIIB/IIIC/IV (see Appendix D) or recurrent ovarian cancer. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for at least 28 days. In addition, patients with primary peritoneal carcinoma or fallopian tube carcinoma may be considered for the study, as long as they are confirmed as being BRCA1 or BRCA2.
    3. Confirmed BRCA1 or BRCA2 status (with a pre existing genetic report & sequence scan). Please note: if there is a strong family history suggesting BRCA (+/-) status but it is unknown, then patients must not be randomised or receive study drug/comparator until a confirmatory genetic test report is received (see Section 5.2.1 for further details). Patients must have BRCA1/2 mutations known to cause loss of gene function (clinical deleterious or suspected deleterious mutations).
    4. One or more measurable lesions, at least 10 mm in the longest diameter (LD) by spiral CT scan, or 20 mm with conventional techniques, according to RECIST criteria, not irradiated within 12 weeks of the first administration of study drug/comparator.
    5. ECOG performance status of 0 2 (see Appendix E).
    6. Estimated life expectancy of at least 16 weeks.
    7. Progressive or recurrent disease after platinum-based chemotherapy. (Note: for patients with recurrence within 12 months of completion of most recent platinum chemotherapy, ie, patients considered resistant or, at best, partially sensitive to platinum, this recurrence does not need to be within 12 months of entering this study. The most recent treatment prior to study entry therefore need not comprise a platinum based regime. Cases where patients whose recurrence has occurred greater than 12 months from completion of most recent platinum chemotherapy, may only be considered for this study if there is a documented medical contra-indication to further platinum chemotherapy and must be discussed and agreed with the Sponsor prior to consent).

    8. Adequate bone marrow, hepatic and renal function, defined as:
    - Haemoglobin ≥9.0 g/dL,
    - White blood cells >3x109/L,
    - Absolute neutrophil count ≥1.5x109/L,
    - Platelets ≥100x109/L,
    - Total bilirubin ≤1.5 x upper limit of normal (ULN),
    - Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤2.5 x ULN (or ≤5x ULN in the presence of liver metastases),
    - Serum creatinine ≤1.5 x ULN.
    9. The patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
    10. The patient has given written informed consent prior to any study related procedure not constituting part of the standard care for the condition, with the understanding that said consent may be withdrawn at any time, without prejudice to any future medical care.
    E.4Principal exclusion criteria
    1. Less than 28 days from active therapy (ie, any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of bisphosphonates if started prior to commencing study treatment and patients may receive palliative radiotherapy for bone disease during the study).
    2. Prior treatment with liposomal doxorubicin.
    3. Prior treatment with anthracyclines as a treatment for ovarian cancer. Patients who have received anthracyclines (non-liposomal doxorubicin or epirubicin) for the treatment of breast cancer are eligible provided the lifetime cumulative dose has not exceeded 240 mg/m2 or 480 mg/m2 respectively at screening.
    4. Patients requiring treatment with inhibitors or inducers of CYP3A4 (see Section 3.5.1 for guidelines and wash-out periods).
    5. Patients with known brain metastases.
    6. Any other malignancy which has been active or treated within the past 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions or endometrial carcinoma stage 1A grade 1. Patients with a history of breast cancer are not eligible if the disease was diagnosed within the past 5 years except for adequately treated stage I or II breast cancer without evidence of recurrent disease. Patients with a history of breast cancer who received definitive treatment can participate even if they received adjuvant treatment during the 5 years prior to screening.
    7. Persistent CTC grade 2 or greater toxicities (excluding alopecia) caused by prior therapy.
    8. Patients currently experiencing seizures or who are currently being treated with any anti epileptic 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 3.5.1).
    9. Major thoracic and/or abdominal surgery in the four weeks prior to the start of study treatment.
    10. Left ventricular ejection fraction below 50%.
    11. 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.
    12. Presence of gastrointestinal disorders that, in the Investigator’s opinion, are likely to interfere with the absorption of AZD2281 or with the patients ability to take regular oral medication.
    13. Patients who are unable to swallow orally administered medication.
    14. Patients who are immunocompromised, eg, patients known to be serologically positive for human immunodeficiency virus (HIV).
    15. A positive pregnancy test. Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used (lack of childbearing potential is met by being post-menopausal or being surgically sterile. Patients of childbearing potential and their partners, who are sexually active, must agree to use two highly effective forms of contraception throughout their participation in the study and for 3 months after the last dose of study drug(s).
    Acceptable Non-hormonal birth control methods include
    · Total sexual abstinence. Abstinence must be for the total duration of the trial and the drug washout period.
    · Vasectomised sexual partner plus male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia
    · Tubal occlusion plus male condom with spermicide
    · IUD plus male condom + spermicide. Provided coils are copper-banded
    Acceptable hormonal methods
    · Etonogestrel implants (e.g., Implanon, Norplan) + male condom with spermicide
    · Normal and low dose combined oral pills + male condom with spermicide
    · Norelgestromin / EE transdermal system + male condom with spermicide
    · Intravaginal device + male condom with spermicide (e.g., EE and etonogestrel)
    · Cerazette (desogestrel) + male condom with spermicide. Cerazette is currently the only highly efficacious progesterone based pill.)
    16. Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
    17. Known hypersensitivity to any of the excipients in the AZD2281 or a conventional formulation of Doxorubicin HCl.
    18. Previous treatment with AZD2281 or other drug with similar mode of action.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to compare the efficacy of AZD2281 with liposomal doxorubicin. This objective will be assessed by the primary variable of PFS and secondary variables of ORR, duration of response, CA 125 level, tumour size and overall survival.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Caelyx (liposomal doxorubicin)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 this 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 years1
    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 years1
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 90
    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 withdrawal from study treatment for whatever reason, patients will be treated 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 Decision2008-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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