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    Summary
    EudraCT Number:2011-006312-31
    Sponsor's Protocol Code Number:D3610C00002
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-27
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2011-006312-31
    A.3Full title of the trial
    A Phase I/II, Multicentre, Study Comprising a Safety Run-In of AZD5363 when Combined with Paclitaxel in Patients with Advanced or Metastatic Breast Cancer; Followed by a Randomised Expansion of AZD5363 when Combined with Paclitaxel vs. Paclitaxel plus Placebo in Patients with ER-Positive Advanced or Metastatic Breast Cancer, Stratified by PIK3CA Mutation Status (BEECH).
    Multicentrická studie fáze I/II sestávající z Run-in fáze hodnocení bezpečnosti podání AZD5363 v kombinaci s paclitaxelem u pacientů s pokročilým nebo metastatickým karcinomem prsu, která je následována randomizovaným rozšířením porovnávajícím podání AZD5363 v kombinaci s paclitaxelem oproti paclitaxelu s placebem u pacientů, rozdělených podle ne/přítomnosti mutace PIK3CA, s ER pozitivním pokročilým nebo metastatickým nádorem prsu (BEECH).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating safety, tolerability and efficacy of AZD5363 when combined with paclitaxel in breast cancer patients.
    Hodnocení bezpečnosti podání AZD5363 v kombinaci s paclitaxelem u pacientů s pokročilým nebo metastatickým karcinomem prsu.
    A.4.1Sponsor's protocol code numberD3610C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01226316
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD5363 80 mg film-coated tablet
    D.3.2Product code AZD5363
    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 INNnot available
    D.3.9.1CAS number 1143532-39-1
    D.3.9.2Current sponsor codeAZD5363
    D.3.9.3Other descriptive name4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxy-propyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-caroxamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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.3.1Product nameAZD5363 200 mg film-coated tablet
    D.3.2Product code AZD5363
    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 INNnot available
    D.3.9.1CAS number 1143532-39-1
    D.3.9.2Current sponsor codeAZD5363
    D.3.9.3Other descriptive name4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxy-propyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-caroxamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Advanced or metastatic breast cancer, ER+ve advanced or metastatic breast cancer, safety and tolerability, pharmacokinetics, pharmacodynamics, tumour response, PIK3CA
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer, side effects, changes in blood levels of drug, effect of drug on body and cancer, breast cancer, an error in the genetic code of an enzyme which drives cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A. Safety run-in: To assess the safety and tolerability of two intermittent dosing schedules of AZD5363 when combined with weekly paclitaxel in patients with advanced or metastatic breast cancer; and to recommend, by assessment of dose limiting toxicities and other safety, tolerability, pharmacokinetic and pharmacodynamic data, a dose and schedule of AZD5363 for further study when combined with weekly paclitaxel.
    Part B. Randomised expansion: To assess the relative efficacy of AZD5363 when combined with weekly paclitaxel compared with weekly paclitaxel plus placebo by assessment of progression-free survival in the overall advanced or metastatic Estrogen Receptor positive breast cancer population and in a Phosphoinositide 3-kinase (PIK3CA) mutation-positive sub-population.
    E.2.2Secondary objectives of the trial
    Part A:To assess anti-tumour activity of AZD5363+paclitaxel by objective response rate and % of patients without progressive disease at 12 w.
    Part B:To assess relative efficacy of AZD5363+paclitaxel vs.paclitaxel+placebo by objective response rate at 12 w., best objective response, durable response rate and duration of response.To assess relative antitumour activity of AZD5363+paclitaxel vs.paclitaxel+placebo by change in tumour size at 12 w.To compare overall survival in patients treated with AZD5363+paclitaxel vs. paclitaxel+placebo by time to death.To further assess safety and tolerability of AZD5363+paclitaxel vs.paclitaxel+placebo.To investigate effects on patients' quality of life of AZD5363+paclitaxel vs.paclitaxel+placebo by changes from baseline, using a patient questionnaire.
    PartsA and B:To assess PK ofAZD5363 and paclitaxel alone and in combination.To assess relationship between plasma AZD5363 exposure and concentrations of plasma biomarkers; toxicity burden of diarrhoea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of informed consent
    Female Patients
    Aged at least 18 years
    Histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be ER+ve, HER2-ve, in Part B).
    World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
    E.4Principal exclusion criteria
    Clinically significant abnormalities of glucose metabolism.
    Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
    Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
    Any prior exposure to agents which inhibit AKT as the primary phamacological activity.
    Part A: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
    Part B: any prior chemotherapy for advanced or metastatic breast cancer.
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Safety and tolerability of AZD5363 when combined with paclitaxel, in terms of numbers of patients with adverse events and serious adverse events.
    Part B: Relative efficacy of AZD5363, compared to placebo, when combined with paclitaxel, by assessment of progression-free survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Regular assessments, to include vital signs, clinical chemistry, haematology and ECGs, will be conducted from screening, throughout the period that patients receive AZD5363/placebo and paclitaxel, up to 28-days following discontinuation of study treatments. Tumour assessments by RECIST 1.1 will be conducted at baseline and every 12 weeks up to disease progression or withdrawal of consent. Recording of adverse events will be conducted from screening, throughout the period that patients receive AZD5363/placebo and paclitaxel, up to 28-days following discontinuation of study treatments. In Part B, serious adverse events that are considered related to study procedures will be recorded up to disease progression.
    E.5.2Secondary end point(s)
    Part A: Preliminary anti-tumour activity of AZD5363 when combined with paclitaxel, by assessment of overall response rate (ORR) and percentage of patients without progressive disease at 12 weeks.
    Part B: Relative efficacy of AZD5363, compared to placebo, when combined with paclitaxel, by assessment of ORR at 12 weeks, best objective response (BOR), duration of response (DoR) and durable response rate (DRR).
    Part B: Relative anti-tumour activity of AZD5363, compared to placebo, when combined with paclitaxel, by comparison of change in tumour size at 12 weeks.
    Part B: Safety and tolerability of AZD5363 when combined with paclitaxel,in terms of numbers of patients with adverse events and serious adverse events.
    Part B: Effect on patient's quality of life (QoL) due to receipt of AZD5363 when combined with paclitaxel, by assessing changes from baseline score in a patient-completed QoL questionnaire (EORTC QLQ-30 / BR-23).
    Parts A and B: Assessment of the plasma concentration profile of AZD5363 when combined with paclitaxel.
    Parts A and B: Assessment of the plasma concentration (PK) profile of paclitaxel alone and when combined with AZD5363
    Parts A and B: Assessment of the pharmacokinetic/pharmacodynamic relationship between plasma concentration of AZD5363 and plasma concentrations of pharmacodynamic biomarkers and correlation with anti-tumour activity.
    Parts A and B: To assess the toxicity burden associated with diarrhoea in relation to the number of episodes, duration of episodes and variations in intensity within episodes of the event's occurrence.
    Part B: Overall survival of patients treated with AZD5363, compared to
    placebo, when in combination with paclitaxel by assessment of time to
    death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Regular assessments, including vital signs, clinical chemistry, haematology and ECGs, will be conducted from screening to 28-days after discontinuation of study treatments. Multiple blood samples for PK/PD assessments will be taken during the first 28-day cycle. Blood sampling for: glycosylated haemoglobin, lipids, circulating tumour cells, and assessment of: MUGA/Echo, QoL and RECIST 1.1, will be conducted every 12 weeks from baseline to disease progression or withdrawal of consent. Adverse events will be recorded from screening to 28-days after discontinuation of study treatments. Part B: serious adverse events that are considered related to study procedures will be recorded up to disease progression; patients will be followed for survival status to death or withdrawal of consent.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Interventional
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    paclitaxel
    E.8.2.4Number of treatment arms in the trial4
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Bulgaria
    Canada
    Czech Republic
    France
    Japan
    Korea, Republic of
    Mexico
    Peru
    Singapore
    Spain
    United Kingdom
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days10
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 140
    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)
    Standard of Care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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