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    The EU Clinical Trials Register currently displays   42762   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-004637-20
    Sponsor's Protocol Code Number:D361DC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-29
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004637-20
    A.3Full title of the trial
    A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
    Randomizowane badanie fazy Ib/III oceniające stosowanie kapiwasertybu w skojarzeniu z palbocyklibem i fulwestrantem w porównaniu z placebo w skojarzeniu z palbocyklibem i fulwestrantem w leczeniu miejscowo zaawansowanego, nieoperacyjnego lub przerzutowego raka piersi z obecnością receptorów hormonalnych i bez obecności receptora ludzkiego naskórkowego czynnika wzrostu typu 2 (CAPItello-292)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase Ib/III Study of Capivasertib + Palbociclib + Fulvestrant as Treatment for HR+/HER2- Advanced Breast Cancer (CAPItello-292)
    Badanie fazy Ib/III oceniające skojarzenie kapiwasertyb + fulwestrant + palbocyklib w leczeniu HR+/HER2- raka piersi opornego na leczenie hormonalne (CAPItello-292)
    A.3.2Name or abbreviated title of the trial where available
    CAPItello-292
    CAPItello-292
    A.4.1Sponsor's protocol code numberD361DC00001
    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 pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailInformation.Center@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 namecapivasertib 160mg 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 INNcapivasertib
    D.3.9.1CAS number 1143532-39-1
    D.3.9.2Current sponsor codeAZD5363
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 namecapivasertib 200mg 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 INNcapivasertib
    D.3.9.1CAS number 1143532-39-1
    D.3.9.2Current sponsor codeAZD5363
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Faslodex 250 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFaslodex 250mg per 5mL solution for injection
    D.3.2Product code ZD9238
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfulvestrant
    D.3.9.1CAS number 129453-61-8
    D.3.9.2Current sponsor codeZD9238
    D.3.9.3Other descriptive nameICI 182780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Hard Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Hard Capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Hard Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Hard Capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Hard Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Hard Capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Film-coated Tablets
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Film-coated Tablets
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 9
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IBRANCE Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIBRANCE Film-coated Tablets
    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 INNpalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    D.8 Placebo: 2
    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
    Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
    Miejscowo zaawansowany, nieoperacyjny lub przerzutowy raka piersi z obecnością receptorów hormonalnych i bez obecności receptora ludzkiego naskórkowego czynnika wzrostu typu 2
    E.1.1.1Medical condition in easily understood language
    HR positive HER2 negative advanced breast cancer
    HR dodatni HER2 negatywny zaawansowany rak piersi
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib:
    To assess the safety and tolerability of capivasertib plus palbociclib and fulvestrant when dosed concomitantly in participants with advanced breast cancer.
    To confirm the RP3D and/or maximum tolerated dose of the triplet combination.

    Phase III:
    To demonstrate the effectiveness of capivasertib plus palbociclib and fulvestrant relative to placebo plus palbociclib and fulvestrant by assessment of PFS in participants with HR+/HER2- locally advanced or metastatic breast cancer (overall population).
    Faza Ib
    Ocena bezpieczeństwa i tolerancji kapiwasertybu w skojarzeniu z palbocyklibem i równocześnie podawanym fulwestrantem u uczestników z zaawansowanym rakiem piersi.
    Potwierdzenie dawki zalecanej do stosowania w fazie III (RP3D) i/lub maksymalnej tolerowanej dawki (MTD) w leczeniu trójlekowym.
    Faza III
    Wykazanie skuteczności kapiwasertybu w skojarzeniu z palbocyklibem i fulwestrantem w porównaniu z placebo w skojarzeniu z palbocyklibem i fulwestrantem na podstawie oceny czasu przeżycia wolnego od progresji (PFS) u uczestników z HR+/HER2- miejscowo zaawansowanym lub przerzutowym rakiem piersi (populacja ogólna).
    E.2.2Secondary objectives of the trial
    Ph Ib:To compare the PKs of palbociclib dosed alone and in combination with capivasertib and fulvestrant. To assess the PKs of capivasertib in combination with palbociclib and fulvestrant. To estimate the effectiveness of capivasertib plus palbociclib and fulvestrant when dosed concomitantly by assessment of ORR,CBR,DoR for participants with measurable disease and PFS in all participants.
    Ph III:To demonstrate the effectiveness of capivasertib plus palbociclib and fulvestrant relative to placebo plus palbociclib and fulvestrant by assessment of: OS, PFS2, ORR, DoR and CBR in participants with HR+/HER2- locally advanced or metastatic breast cancer (overall population).PFS in participants with HR+/HER2- locally advanced or metastatic breast cancer and gene alterations detected in PIK3CA, AKT1 and/or PTEN.To assess participant reported symptoms, functioning, HRQoL,and overall functional status as well as the safety and tolerability (overall population).To evaluate the PK of capivasertib.
    Faza Ib: Porównanie PK palbocyklibu w monoterapii i w skojarzeniu z kapiwasertyb+ fulwestrant. Ocena PK kapiwasertybu w skojarzeniu z palbocyklib+fulwestrant. Ocena skuteczności kapiwasertybu w skojarzeniu z palbocyklibem + równocześnie podawany fulwestrant na podstawie oceny ORR, CBR, DoR u pacjentów z mierzalną chorobą oraz PFS u wszystkich pacjentów.
    Faza III: Wykazanie skuteczności kapiwasertybu w skojarzeniu z palbocyklib+fulwestrant vs placebo w skojarzeniu z palbocyklib+fulwestrant na podstawie oceny OS, PFS2, ORR, DoR i CBR u uczestników z HR+/HER2- miejscowo zaawansowanym lub przerzutowym rakiem piersi (populacja ogólna). PFS u uczestników z HR+/HER2- miejscowo zaawansowanym lub przerzutowym rakiem piersi i z wykrytymi zmianami genetycznymi w genie PIK3CA, AKT1 i/lub PTEN. Ocena objawów opisywanych przez uczestników, funkcjonowania, HRQoL i ogólnego stanu czynnościowego, a także bezpieczeństwa i tolerancji (populacja ogólna). Ocena PK kapiwasertybu.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria for both phases:
    1. Adult females (pre- and/or post-menopausal), and adult males.
    2. Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
    3. Eligible for palbociclib and fulvestrant therapy as per investigator assessment.
    4. Adequate organ and bone marrow functions.
    5. Consent to provide a mandatory FFPE tumour sample.

    Inclusion criteria only for phase III:
    1. Radiologic measurable relapse during neoadjuvant / adjuvant endocrine therapy or evidence of relapse within 12 months of completion of adjuvant therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer.
    2. Received up to a maximum of 1 lines of prior chemotherapy in the advanced setting.
    Kryteria włączenia wspólne dla obu faz badania:
    1. Dorosłe kobiety (w wieku przed-/około-/pomenopauzalnym) oraz dorośli mężczyźni
    2. Potwierdzony histologicznie HR+/HER2− rak piersi według oceny najnowszej pobranej próbki nowotworu (pierwotnego lub przerzutowego), zgodnie z wytyczną American Society of Clinical Oncology i College of American Pathologists. Aby było spełnione wymaganie choroby HR+, rak piersi musi wykazywać ekspresję ER z równoczesną ekspresją receptora progesteronowego lub bez.
    3. Uczestnicy muszą się kwalifikować do leczenia palbocyklibem i fulwestrantem zgodnie z oceną badacza
    4. Wydolna czynność narządów i szpiku kostnego
    5. Zgoda to przekazanie obowiązkowej próbki guza w postaci FFPE

    Kryteria włączenia dotyczące fazy III:
    1. Objawy radiologiczne nawrotu lub progresji raka piersi w trakcie stosowania lub w ciągu 12 miesięcy od zakończenia (neo)adjuwantowego leczenia hormonalnego lub progresji w trakcie pierwszych 12 miesięcy wcześniejszego ET podawanego jako 1. rzut leczenia z powodu miejscowo zaawansowanego nieoperacyjnego lub przerzutowego raka piersi.
    2. Przyjęcie maksymalnie jednej linii wcześniejszej chemioterapii w stadium zaawansowanym.
    E.4Principal exclusion criteria
    Key exclusion criteria for both phases:
    1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
    2. Radiotherapy with a wide field of radiation within 4 weeks prior to study treatment initiation and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study treatment initiation. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received.
    3. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
    4. Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study physician.
    5. Spinal cord compression, brain metastases or leptomeningeal metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.
    6. Any of the following cardiac criteria at screening:
    (a). Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs
    (b). Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block)
    (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
    (d). Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association
    (NYHA) grade ≥ 2
    (e). Uncontrolled hypotension
    (f). Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher)
    7. Any of these clinically significant abnormalities of glucose metabolism at screening:
    (a). diabetes mellitus type I or type II requiring insulin treatment
    (b). HbA1c ≥ 8.0% (63.9 mmol/mol)
    8. Previous allogeneic bone marrow transplant or solid organ transplant.
    9. For the phase III: Prior treatment with CDK4/6 inhibitors (any setting), a SERD (including unlicensed SERDs), allosteric mTOR inhibitors (e.g. everolimus), PI3K inhibitors (e.g. alpelisib) or AKT inhibitors.
    Kryteria włączenia wspólne dla obu faz badania:
    1. Inny pierwotny nowotwór złośliwy w wywiadzie, z wyjątkiem nowotworu złośliwego wyleczonego radykalnie i bez objawów czynnej choroby w okresie ≥ 5 lat przed pierwszą dawką badanej interwencji, z niskim potencjalnym ryzykiem nawrotów.
    2. Radioterapia na szerokie pole napromieniowania w ciągu 4 tygodni przed rozpoczęciem badanego leczenia i/lub radioterapia na ograniczone pole napromieniowania w celach paliatywnych w ciągu 2 tygodni przed rozpoczęciem badanego leczenia. Pacjenci, których poddano wcześniejszej radioterapii z napromieniowaniem ≥25% szpiku kostnego, nie kwalifikują się do udziału w badaniu, niezależnie od tego, kiedy została przeprowadzona.
    3. Poważny zabieg chirurgiczny (z wyjątkiem założenia dostępu naczyniowego) lub istotny uraz traumatyczny w ciągu 4 tygodni przed pierwszą dawką badanej interwencji.
    4. Utrzymujące się objawy toksyczności (stopnia > 1 według CTCAE) wcześniejszego leczenia przeciwnowotworowego, z wyłączeniem łysienia. Uczestnicy z nieodwracalnymi działaniami toksycznymi, które według racjonalnych przesłanek nie powinny nasilić się w wyniku zastosowania badanej interwencji (np. z utratą słuchu), mogą zostać włączeni do badania po konsultacji z lekarzem prowadzącym badanie z ramienia firmy AstraZeneca.
    5. Zespół ucisku rdzenia kręgowego, przerzuty do mózgu lub przerzuty do opon miękkich, chyba że są bezobjawowe, leczone i stabilne oraz nie wymagały leczenia steroidami przez okres 4 tygodni przed rozpoczęciem badanego leczenia.
    6. Spełnienie dowolnego z poniższych kryteriów kardiologicznych podczas oceny przesiewowej:
    a. średni skorygowany spoczynkowy odstęp QT (QTc) > 470 ms na podstawie 3 kolejnych badań EKG
    b. jakiekolwiek istotne klinicznie zaburzenia rytmu, przewodzenia lub morfologii w spoczynkowym badaniu EKG (np. całkowity blok lewej odnogi pęczka Hisa, blok serca III stopnia)
    c. jakiekolwiek czynniki zwiększające ryzyko wydłużenia odstępu QTc lub ryzyko epizodów zaburzeń rytmu serca
    d. którakolwiek z następujących procedur lub chorób w ciągu ostatnich 6 miesięcy: zabieg pomostowania aortalno-wieńcowego, angioplastyka, stent naczyniowy, zawał serca, choroba niedokrwienna serca, zastoinowa niewydolność serca stopnia ≥2 wg klasyfikacji Nowojorskiego Towarzystwa Kardiologicznego (NYHA)
    e. niewyrównane niedociśnienie tętnicze – skurczowe ciśnienie tętnicze (SBP) <90 mmHg i/lub rozkurczowe ciśnienie tętnicze (DBP) <50 mmHg
    f. frakcja wyrzutowa serca poza granicą normy w danej instytucji lub <50% (jeśli jest większa), oznaczona na podstawie echokardiogramu (lub badania MUGA, jeśli nie można wykonać echokardiogramu lub jego wynik jest niejednoznaczny)
    7. Istotne klinicznie nieprawidłowości metabolizmu glukozy stwierdzone na podstawie spełnienia dowolnego z poniższych warunków podczas oceny przesiewowej:
    a. Pacjenci z cukrzycą typu I lub z cukrzycą typu II wymagającą insulinoterapii
    b. HbA1c ≥8,0% (63,9 mmol/mol)
    8. Przebyty allogeniczny przeszczep szpiku kostnego lub przeszczep narządu miąższowego
    9. Dla fazy III: Wcześniejsze leczenie inhibitorami CDK4/6, lekiem z grupy SERD (w tym niezarejestrowanym lekiem SERD), inhibitorami mTOR (np. everolimus), inhibitorami PI3K (np. alpelisyb) lub inhibitorami AKT


    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib:
    Safety and tolerability will be evaluated in terms of DLTs, AEs/SAEs, vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters.The measures of interest are subject incidence rates, absolute values and change from baseline over time.
    Phase III:
    PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by the investigator or death due to any cause.
    Faza Ib
    Bezpieczeństwo i tolerancja będą oceniane na podstawie na podstawie toksyczności ograniczającej dawkę (DLT), zdarzeń niepożądanych/ciężkich zdarzeń niepożądanych (AE/SAE), podstawowych parametrów życiowych, badań biochemicznych/hematologicznych/metabolizmu glukozy i parametrów EKG.
    Istotnymi wynikami pomiarów są wskaźniki częstości występowania u pacjentów, wartości bezwzględne i zmiana w stosunku do stanu wyjściowego z czasem.
    Faza III
    PFS zdefiniowano jako czas od randomizacji do progresji choroby w ocenie badacza wg kryteriów RECIST w wersji 1.1 lub do zgonu pacjenta z dowolnej przyczyny.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase Ib: Assessed at the end of the Phase Ib study and throughout by the Safety Review Committee after each cohort of DLT-evaluable participants have completed Cycle 1 (28 days) or experienced a DLT within cycle one.
    Phase III: Up to approximately 33 months from first subject randomised.
    Faza Ib: Oceniane na koniec fazy Ib badania i przez cały czas przez Komisję Monitorowania Bezpieczeństwa po tym, jak każda kohorta uczestników podlegających ocenie DLT zakończyła cykl 1 (28 dni) lub doświadczyła DLT w pierwszym cyklu.
    Faza III: Do około 33 miesięcy od zrandomizowania pierwszego pacjenta.
    E.5.2Secondary end point(s)
    Phase Ib:
    1.Palbociclib PK parameters: Cmax, AUC0-72h (Cycle 0), AUC0-24h (Cycle 1), Cmin (Cycle 1)
    2.Plasma PK parameters derived from a population PK model, as permitted by the data.
    3.Capivasertib PK parameters: Cmax, AUC0-12h, Cmin
    Plasma PK parameters derived from a population PK model, as permitted by the data.
    4. ORR
    5. CBR at 24 weeks
    6. DoR
    7. PFS
    Phase III:
    1. OS
    2. PFS in PIK3CA/AKT1/PTEN - altered population
    3. PFS2
    4. ORR
    5. DoR
    6. CBR at 24 weeks
    7. EORTC QLQ-30 and EORTC QLQ-BR45
    8. Time to definitive deterioration.
    9. Plasma concentration of capivasertib pre-dose (Ctrough), and post-dose (C1h and C4h) in the
    overall population (participants randomised to capivasertib + fulvestrant + palbociclib)
    Plasma PK parameters derived from a population PK model, as permitted by the data.
    10. Safety and tolerability will be evaluated in terms of AEs/SAEs, vital signs, clinical chemistry/haematology/glucose metabolism parameters, and ECG parameters.
    The measures of interest are subject incidence rates, absolute values and change from baseline over time.
    Faza Ib:
    1. Parametry PK palbocyklibu: Cmax, AUC0-72h (cykl 0), AUC0-24h (cykl 1), Cmin (cykl 1)
    2. Parametry PK w osoczu obliczone z użyciem populacyjnego modelu FK, na ile pozwolą na to dane
    3. Parametry FK kapiwasertybu: Cmax, AUC0-12h, Cmin
    Parametry FK w osoczu obliczone z użyciem populacyjnego modelu FK, na ile pozwolą na to dane
    4. ORR
    5. CBR po 24 tygodniach
    6. DOR
    7. PFS
    Faza III
    1. OS
    2. PFS w populacja ze zmianami w genie PIK3CA/AKTA/PTEN
    3. PFS2
    4. ORR
    5. DoR
    6. CBR po 24 tygodniach
    7. Kwestionariusze EORTC QLQ-30 i EORTC QLQ-BR45
    8. Czas do definitywnego pogorszenia
    9. Stężenie kapiwasertybu w osoczu przed podaniem leku (Ctrough) i po dawce leku (C1h i C4h) w populacji ogólnej (uczestnicy przydzieleni losowo do grupy otrzymującej kapiwasertyb + fulwestrant + palbocyklib)
    Parametry FK w osoczu obliczone z użyciem populacyjnego modelu FK, na ile pozwolą na to dane
    10.Bezpieczeństwo i tolerancja będą oceniane na podstawie AE/SAE, podstawowych parametrów życiowych, badań biochemicznych/hematologicznych/metabolizmu glukozy i parametrów EKG.
    Istotnymi wynikami pomiarów są wskaźniki częstości występowania u pacjentów, wartości bezwzględne i zmiana w stosunku do stanu wyjściowego z czasem.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase Ib:
    At the end of the Phase Ib study.

    Phase III:
    1. Up to approximately 60 months from first subject randomised
    2. Up to approximately 33 months from first subject randomised
    3. Up to approximately 60 months from first subject randomised
    4. Up to approximately 33 months from first subject randomised
    5. Up to approximately 33 months from first subject randomised
    6. Up to approximately 33 months from first subject randomised
    7. Up to approximately 60 months from first subject randomised
    8. Up to approximately 60 months from first subject randomised
    9. Up to approximately 33 months from first subject randomised
    10. Up to approximately 33 months from first subject randomised
    Faza Ib:
    Oceniane na koniec fazy Ib.

    Faza III:
    1. Do około 60 miesięcy od zrandomizowania pierwszego pacjenta
    2. Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    3. Do około 60 miesięcy od zrandomizowania pierwszego pacjenta
    4. Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    5. Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    6. Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    7. Do około 60 miesięcy od zrandomizowania pierwszego pacjenta
    8. Do około 60 miesięcy od zrandomizowania pierwszego pacjenta
    9. Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    10.Do około 33 miesięcy od zrandomizowania pierwszego pacjenta
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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
    Ib
    Ib
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Faza Ib: otwarte, z możliwością grup równoległych, Faza III: randomizowane, podwójnie zaślepione
    Phase Ib: Open, Parallel groups allowed, Phase III: Randomised, double blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Faza Ib: niekontrolowana, Faza III: kontrolowana, placebo +terapia standardowa (SoC)
    Phase Ib: not controlled, Phase III: controlled - placebo + SoC
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Denmark
    France
    Poland
    Sweden
    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 study is defined as the last visit/contact of the last patient undergoing the study. For phase Ib, there will be a data cutoff defined as the earlier of 6 months after the last patient enrolled starts study treatment, or 30 days after the final patient discontinues treatment. As the phase III is event driven, the accrual of the predetermined number of events included in the study endpoints will determine the duration of the data collection phase of the study.
    Zakończenie badania podano jako ostatnią wizytę/kontakt ostatniego uczestnika. W fazie Ib będzie wyznaczona data graniczna zbierania danych do analizy: 6 msc. po rozpoczęciu leczenia przez ostatniego włączonego pacjenta, lub 30 dni po zakończeniu leczenia przez ostatniego pacjenta – zależy które nastąpi wcześniej.
    Ponieważ faza III jest zależna od liczby zdarzeń, uzyskanie zdefiniowanej liczby zdarzeń z punktów końcowych będzie determinować okres wymagany do ich zebrania.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 525
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Non-sterilised male participants are sexually active must be using contraception’s method
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 560
    F.4.2.2In the whole clinical trial 700
    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)
    Post treatment follow up 30 days after last dose
    30-dniowy okres obserwacji po przyjęciu ostatniej dawki
    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 Decision2021-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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