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    EudraCT Number:2006-006458-91
    Sponsor's Protocol Code Number:KU36-44
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2006-006458-91
    A.3Full title of the trial
    A phase II, open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 given orally twice daily in patients with advanced BRCA1- or BRCA2-associated breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberKU36-44
    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 SponsorKuDOS Pharmaceuticals Ltd. (a member of the AstraZeneca group of companies)
    B.1.3.4CountryUnited Kingdom
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code 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 codeKU-0059436
    D.3.9.3Other descriptive name4-[3-(Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2-H-phthalazin-1-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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 breast cancer (stage IIIB/IIIC/IV) and confirmed BRCA+ status
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of KU 0059436 at two dose levels in terms of objective tumour response rate when administered orally to patients with advanced BRCA1- or BRCA2-associated breast cancer.
    E.2.2Secondary objectives of the trial
    •To assess the efficacy of KU-0059436 at two dose levels in terms of clinical benefit rate (complete response [CR] and partial response [PR] and stable disease [SD]) at various timepoints and progression-free survival (PFS) when administered orally to patients with advanced BRCA1- or BRCA2-associated breast cancer.
    •To investigate the pharmacodynamic profiles of two different dose levels of KU-0059436 in peripheral blood mononuclear cells (PBMCs).
    •To assess the safety & tolerability profile of KU 0059436 at two dose levels when administered orally to patients with advanced BRCA1- or BRCA2-associated breast cancer.
    •To determine exposure to KU 0059436 at two dose levels following oral administration to patients with advanced BRCA1- or BRCA2-associated breast cancer.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female, aged 18 years or older.
    2. Histologically or cytologically confirmed breast cancer that is locally advanced (not amenable to curative surgery and/or radiation) or has metastasised (Stage IIIB/IIIC or IV, respectively, according to the American Joint Committee on Cancer Criteria). This includes patients who develop metastatic disease at the time of relapse. 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.
    3. Confirmed BRCA1 or BRCA2 status (with a pre-existing genetic report & sequence scan). Please note: if there is a strong family history and evidence suggesting BRCA-/- status, then patients may be screened for the study, but must not receive IMP until a confirmatory Myriad Genetics sequence 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 IMP.
    5. ECOG performance status of 0 – 2 (see Appendix 6).
    6. Estimated life expectancy of at least 16 weeks.
    7. Failed at least one prior chemotherapy and/or endocrine therapy in the advanced/metastatic setting, and for whom, in the opinion of the Investigator, no curative standard therapy exists. Patients whose tumours are histologically Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+) must have had at least one line of hormonal therapy, for which there will have to be a washout period of at least 28 days prior to trial entry.
    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 ≤ 5 x 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 anti-cancer therapy such as chemotherapy, endocrine therapy, antibody-based therapy (e.g. trastuzumab) or high dose radiotherapy. Patients may continue concomitant use of bisphosphonates if used for at least 28 days prior to commencing study treatment and patients may receive palliative radiotherapy for bone disease during the study.
    2. Patients requiring treatment with inhibitors or inducers of CYP3A4 (see Section 3.5.1 for guidelines and wash-out periods).
    3. Patients with brain metastases or central nervous system metastases that have any of the following features: 1) are progressive or have been symptomatic within 28 days of starting study treatment, 2) have not been resected or irradiated, 3) are the only site of measurable disease.
    4. 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. Patients with a history of ovarian cancer within the past 5 years are eligible in the case of adequately treated stage I or II ovarian cancer without any suspicion of recurrent disease such as peritoneal spread or increased CA-125 levels.
    5. Persistent CTC grade 2 or greater toxicities (excluding alopecia) caused by prior therapy..
    6. 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).
    7. Major thoracic and/or abdominal surgery in the four weeks prior to the start of study treatment.
    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. Presence of gastrointestinal disorders that, in the Investigator’s opinion, are likely to interfere with the absorption of the IMP.
    10. Patients who are unable to swallow orally administered medication.
    11. Patients who are immunocompromised, e.g. patients known to be serologically positive for human immunodeficiency virus (HIV).
    12. 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, being surgically sterile, practising contraception with an oral contraceptive or other hormonal therapy [e.g. hormone implants], intra-uterine device, diaphragm with spermicide or condom with spermicide, or being sexually inactive. Patients and their partners must agree to use one of the above forms of contraception throughout the treatment period and for 3 months after discontinuation of treatment).
    13. Simultaneous participation in any other study involving an IMP, or having participated in a study less than 28 days prior to the start of study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    • To assess the Objective Tumour Response Rate (proportion of patients with tumour response of CR + PR) of two dose levels of KU 0059436 after 4 cycles of treatment when administered orally to patients with advanced BRCA1 and BRCA2-associated breast cancer.
    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 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. 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 No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 the study is defined as 6 months post-Last Patient In or after approval of amendment 4, whichever is the later
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 23
    F.4.2.2In the whole clinical trial 54
    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 the end of study, visits are conducted at study site as per local clinical practice until the patient is no longer deriving clinical benefit. Any patient who, in the opinion of the investigator, is obtaining a clinical benefit and is tolerating the treatment without dose-limiting toxicities at the end of the study may consent to continue to receive KU-0059436 until such time that a clinical benefit is no longer apparent.
    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 Decision2007-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
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