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    Summary
    EudraCT Number:2018-000764-29
    Sponsor's Protocol Code Number:D933LC00001
    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:2018-12-19
    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 number2018-000764-29
    A.3Full title of the trial
    A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First line Metastatic Triple Negative Breast Cancer
    Wieloośrodkowe, dwuetapowe, badanie fazy IB/II prowadzone metodą otwartej próby, oceniające skuteczność i bezpieczeństwo durwalumabu (MEDI4736) + paklitakselu i durwalumabu (MEDI4736) w połączeniu z nowymi lekami onkologicznymi z paklitakselem lub bez paklitakselu w pierwszej linii leczenia przerzutowego, potrójnie negatywnego raka piersi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IB/II Study to determine efficacy and safety of Durvalumab + Paclitaxel and Durvalumab in Combination with Novel Oncology Therapies with or without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer
    Badanie fazy IB/II oceniające skuteczność i bezpieczeństwo durwalumabu + paklitakselu i durwalumabu w połączeniu z nowymi lekami onkologicznymi z paklitakselem lub bez paklitakselu w pierwszej linii leczenia potrójnie negatywnego raka piersi
    A.3.2Name or abbreviated title of the trial where available
    BEGONIA
    BEGONIA
    A.4.1Sponsor's protocol code numberD933LC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03742102
    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
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.2Town/ citySodertaije
    B.5.3.3Post codeSE151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+1 87 72409 479
    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 namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameMEDI4736
    D.3.9.4EV Substance CodeAS1
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    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 nameOleclumab
    D.3.2Product code MEDI9447
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEDI9447
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeMEDI9447
    D.3.9.3Other descriptive nameMEDI9447
    D.3.9.4EV Substance CodeAS4
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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
    D.3.2Product code AZD5363
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameAZD5363
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number160 to 200
    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 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 nameTrastuzumab Deruxtecan
    D.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrastuzumab Deruxtecan
    D.3.9.1CAS number 1826843-81-5
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameAnti-HER2 Antibody-Drug Conjugate
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibody drug conjugate
    D.IMP: 5
    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 nameDatopotamab deruxtecan
    D.3.2Product code Dato-DXd
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDatopotamab deruxtecan
    D.3.9.1CAS number 2238831-60-0
    D.3.9.2Current sponsor codeDS-1062a
    D.3.9.3Other descriptive nameAnti-trophoblast cell surface protein 2 (TROP2) antibody-drug conjugate
    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) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibody-Drug Conjugate
    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
    First-line (1L) Stage IV Triple Negative Breast Cancer (TNBC) - the subtype of breast cancer characterized by a lack of tumor expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2.
    Pierwsza linia (1L) leczenia potrójnie negatywnego raka piersi (TNBC) w stadium IV, podtypu raka piersi charakteryzującego się brakiem ekspresji receptorów estrogenowych i progesteronowych oraz receptora ludzkiego naskórkowego czynnika wzrostu 2 (HER2) w nowotworze.
    E.1.1.1Medical condition in easily understood language
    Treatment of first line (1L) metastatic triple negative breast cancer (TNBC).
    Leczenie pierwszej linii (1l) potrójnie negatywnego raka piersi z przerzutami (TNBC)
    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 PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1:
    To assess the safety and tolerability profile of durvalumab + novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel.

    Part 2:
    To assess the efficacy of durvalumab + novel oncology therapies with or without paclitaxel in terms of ORR.
    Cześć 1:
    Ocena bezpieczeństwa stosowania i tolerancji leczenia skojarzonego durwalumabu i nowych terapii onkologicznych z/bez zastosowania paklitakselu oraz leczenia skojarzonego durwalumabu i paklitakselu

    Część 2:
    Ocena skuteczności leczenia skojarzonego durwalumabu i nowych terapii onkologicznych z/bez zastosowania paklitakselu pod względem odsetka odpowiedzi obiektywnych (ORR)
    E.2.2Secondary objectives of the trial
    Part 1:
    1. To assess the efficacy of durvalumab + novel oncology therapies with or without paclitaxel and
    durvalumab + paclitaxel in terms of ORR, PFS, DoR, and OS

    2. To assess the PK of durvalumab and novel oncology therapies in all treatment arms.

    3. To investigate the immunogenicity of durvalumab and novel oncology therapies in all applicable treatment arms.

    Part 2:
    1. To assess the efficacy of durvalumab + novel oncology therapies with or without paclitaxel in terms of PFS, DoR, PFS6 and OS.

    2.To assess the safety and tolerability profile of durvalumab + novel oncology therapies with or without paclitaxel.
    Cześć 1:
    1. Ocena skuteczności skojarzenia durwalumabu + paklitakselu + nowej terapii onkologicznej oraz durwalumabu + paklitakselu pod względem odsetka odpowiedzi obiektywnych (ORR), przeżycia bez progresji choroby (PFS), czasu trwania odpowiedzi (DoR) i przeżycia całkowitego (OS);
    2. Ocena farmakokinetyki (PK) durwalumabu i nowych terapii onkologicznych we wszystkich grupach leczenia;
    3. Ocena immunogenności durwalumabu i nowych terapii onkologicznych we wszystkich odpowiednich grupach leczenia.
    Część 2:
    1. Ocena skuteczności leczenia skojarzonego durwalumabu i nowych terapii onkologicznych z/bez zastosowania paklitakselu pod względem PFS, DoR, przeżycia bez progresji choroby po 6 miesiącach (PFS6) i OS
    2. Ocena profilu bezpieczeństwa i tolerancji leczenia skojarzonego durwalumabu i nowych terapii onkologicznych z/bez zastosowania paklitakselu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female
    2. At least 18 years of age at the time of screening
    3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC
    4. No prior treatment for metastatic (Stage IV) TNBC
    5. Patient must have at least 1 lesion, not previously irradiated, that can
    be accurately measured
    6. WHO/ECOG status at 0 or 1 at enrollment

    Patients enrolled to Arm 6 (durvalumab and DS-8201a)
    Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH–, IHC 1+/ISH–, or IHC 1+/ISH untested)
    1. Kobiety;
    2. Wiek ≥18 lat podczas oceny przesiewowej.
    3. Lokalnie potwierdzony potrójnie negatywny zaawansowany/nieoperacyjny lub przerzutowy rak piersi (TNBC)
    4. Pacjenci nieleczeni wcześniej z powodu przerzutowego potrójnie negatywnego raka piersi (stopień IV).
    5. Co najmniej jedna zmiana, która nie była wcześniej naświetlana i która może być dokładnie oceniona;
    6. Stan sprawności wg skali Światowej Organizacji Zdrowia (WHO)/Eastern Cooperative Oncology Group (ECOG) 0 lub 1 w chwili kwalifikacji do udziału w badaniu;

    Pacjenci włączani do ramienia terapeutycznego 6 (durwalumab + DS-8201a)
    Wymagane jest udokumentowanie lokalnie określonego zaawansowanego/nieoperacyjnego lub przerzutowego TNBC z niską ekspresją HER2 guza (IHC2+/ISH-, IHC 1+/ISK-, lub IHC 1+/ISH niebadane)
    E.4Principal exclusion criteria
    1. History of allogeneic organ transplantation
    2. Active or prior documented autoimmune or inflammatory disorders
    3. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
    4. Untreated CNS metastases
    5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
    6. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
    7. Female patients who are pregnant, breastfeeding
    8. Cardiac Ejection Fraction less than 50%

    Patients enrolled in Arm 2 only:

    1. Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort)
    2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment

    Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months

    Patients enrolled in Arm 7 only: Clinically significant corneal disease in the opinion of the Investigator.

    Patients enrolled in Arm 6 and 7 only:

    1. History of or active interstitial lung disease/pneumonitis
    2. Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a
    (Arm 6) or Dato-DXd (Arm 7) treatment
    3. Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received
    HER2-targeted therapy.
    1.Allogeniczny przeszczep narządów w wywiadzie
    2.Udokumentowane aktywne lub wcześniej przebyte choroby autoimmunologiczne lub zapalne
    3.Aktywne zakażenie, w tym gruźlica, wirusowe zapalenie wątroby typu B (stwierdzony dodatni wynik badania na obecność antygenu powierzchniowego [HBsAg] wirusa zapalenia wątroby typu B [HBV]), wirusowe zapalenie wątroby typu C (HCV), lub zakażenie ludzkim wirusem niedoboru odporności (dodatni wynik badania na obecność przeciwciał przeciw wirusowi HIV 1/2).
    4.Nieleczone przerzuty do OUN
    5.Znana alergia lub nadwrażliwość na którykolwiek z badanych leków lub którąkolwiek z substancji pomocniczych badanego leku
    6.Jakakolwiek jednoczesna chemioterapia, IP lub terapia biologiczna w leczeniu raka
    7.Kobiety w ciąży, karmiące piersią
    8.Frakcja wyrzutowa serca mniejsza niż 50%

    Pacjenci włączani do ramienia terapeutycznego 2:
    1. Silne inhibitory lub induktory lub substraty CYP3A4 lub substraty CYP2C9 lub CYP2D6 w ciągu 2 tygodni przed podaniem pierwszej dawki badanego leku (3 tygodnie w przypadku dziurawca zwyczajnego)
    2. Rozpoznanie cukrzycy typu 1 lub cukrzyca typu 2 wymagająca podania insuliny

    Pacjenci włączani do ramienia terapeutycznego 7:
    W opinii Badacza klinicznie istotna choroba rogówki

    Pacjenci włączani do ramienia terapeutycznego 6 i 7:
    1. Śródmiąższowa choroba płuc/zapalenie płuc w wywiadzie
    2. Stosowanie chlorochiny lub hydroksychlorochiny w okresie <14 dni przed 1. dniem leczenia DS-8201a (Ramię 6) lub Dato-DXd (Ramię 7)
    3. Pacjenci włączeni tylko do ramienia 6: Wcześniej zdiagnozowani jako HER2 + lub otrzymali terapię ukierunkowaną na HER2.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    1. AEs, exposure, physical examinations, laboratory findings, and vital signs

    Part 2:
    Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).
    Część 1:
    1. Zdarzenia niepożądane, ekspozycja, badania przedmiotowe, wyniki badań laboratoryjnych i podstawowe parametry życiowe

    Część 2:
    Punkty końcowe oparte o ocenę badacza według kryteriów RECIST 1.1: odsetek odpowiedzi obiektywnych (ORR): odsetek pacjentów kwalifikujących się do oceny z potwierdzoną odpowiedzią całkowitą (CR) lub odpowiedzią częściową (PR) podczas wizyty w ocenie badacza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1:
    1. During treatment through 90 days after last dose of investigational product

    Part 2:
    During treatment through 180 days after last dose of investigational product
    Część 1:
    1. W trakcie leczenia oraz przez 90 dni po przyjęciu ostatniej dawki badanego produktu

    Część 2:
    W trakcie leczenia oraz przez 180 dni po przyjęciu ostatniej dawki badanego produktu
    E.5.2Secondary end point(s)
    Part 1:

    1. Endpoints based on Investigator assessment according to RECIST 1.1:
    - ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response)

    - PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)

    - DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression

    -OS (overall survival): Time from date of first dose until the date of death by any cause

    2. Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies

    3. Presence of ADAs for durvalumab and applicable novel oncology therapies

    Part 2:

    1. Endpoints based on Investigator assessment according to RECIST 1.1:
    - PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)

    - DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression

    - PFS6: PFS at 6 months following date of first dose

    - OS (overall survival): Time from date of first dose until the date of death by any cause

    2. AEs, exposure, physical examinations, laboratory findings, and vital signs
    Część 1:
    1. Punkty końcowe oparte o ocenę badacza według kryteriów RECIST 1.1:
    • ORR: odsetek pacjentów kwalifikujących się do oceny z potwierdzoną odpowiedzią całkowitą (CR) lub odpowiedzią częściową (PR) podczas wizyty w ocenie badacza;
    • PFS: czas od daty przyjęcia pierwszej dawki do dnia stwierdzenia obiektywnej radiologicznej progresji choroby zgodnie z kryteriami RECIST 1.1 lub zgonu (z dowolnej przyczyny przy braku progresji);
    • DoR: czas od dnia wykrycia po raz pierwszy obiektywnej odpowiedzi do dnia stwierdzenia obiektywnej radiologicznej progresji choroby;
    • OS: czas od daty przyjęcia pierwszej dawki do dnia zgonu z dowolnej przyczyny;
    2. Stężenie durwalumabu w osoczu oraz stężenie nowych terapii onkologicznych w krwi i w osoczu;
    3. Obecność przeciwciał przeciwlekowych (ADA) dla durwalumabu i nowych terapii onkologicznych

    Część 2:
    1. Punkty końcowe oparte o ocenę badacza według kryteriów RECIST 1.1:
    • PFS: czas od daty przyjęcia pierwszej dawki do dnia stwierdzenia obiektywnej radiologicznej progresji choroby zgodnie z kryteriami RECIST 1.1 lub zgonu (z dowolnej przyczyny przy braku progresji);
    • DoR: czas od dnia wykrycia po raz pierwszy obiektywnej odpowiedzi do dnia stwierdzenia obiektywnej radiologicznej progresji choroby;
    • PFS6: czas wolny od progresji choroby po 6 miesiącach od daty przyjęcia pierwszej dawki;
    • OS: czas od daty przyjęcia pierwszej dawki do dnia zgonu z dowolnej przyczyny;
    2. Zdarzenia niepożądane, badania przedmiotowe, wyniki badań laboratoryjnych i podstawowe parametry życiowe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During treatment through 90 days after last dose of investigational product

    2. During treatment through 180 days after last dose of investigational product
    1. W trakcie leczenia oraz przez 90 dni po przyjęciu ostatniej dawki badanego produktu;
    2. W trakcie leczenia oraz przez 180 dni po przyjęciu ostatniej dawki badanego produktu.
    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 No
    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
    This protocol has the potential for future treatment arms to be added via protocol amendment
    Protokół zawiera możliwość dołączenia kolejnych ramion poprzez poprawki do protokołu
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    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 concerned11
    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 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
    Canada
    Korea, Republic of
    Poland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 study is defined as the last expected visit/contact of the last patient undergoing the study.
    Zakończenie badania zdefiniowano jako ostatnią przewidzianą wizytę/kontakt z ostatnim pacjentem uczestniczącym w badaniu.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.1.6.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 221
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Once patients have been discontinued from study treatment, other treatment options including standard of care will be at the discretion of the investigator.
    Po zakończeniu przyjmowania leczenia wynikającego z protokołu badania, propozycja możliwości dalszego leczenia, z uwzględnieniem standardowej opieki medycznej, będę w gestii Badacza
    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 Decision2019-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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