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    Summary
    EudraCT Number:2017-004632-11
    Sponsor's Protocol Code Number:D081RC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-12-21
    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 number2017-004632-11
    A.3Full title of the trial
    A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).
    Wieloośrodkowe randomizowane badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające stosowanie durwalumabu w skojarzeniu z chemioterapią i bewacyzumabem, z terapią podtrzymującą durwalumabem, bewacyzumabem i olaparybem u pacjentek z nowo rozpoznanym, zaawansowanym rakiem jajnika (DUO-O)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a phase III randomised, double-blind, placebo-controlled, multi-centre, global study to assess the effectiveness and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance therapy of bevacizumab either alone, or in combination with durvalumab, or in combination with durvalumab and olaparib in patients newly diagnosed with advanced ovarian cancer.
    Jest to, randomizowane, prowadzone metodą podwójnie ślepej próby z kontrolą placebo, wieloośrodkowe,globalne badanie fazy III, oceniające skuteczność i bezpieczeństwo standardwoej chemioterapii (SoC) na bazie platyny i bewacyzumabu z dalszym leczeniem podtrzymującym bewacyzumabem zarówno w monoterapii, jak i w skojarzeniu z durwalumabem (MEDI4736) lub w skojarzeniu z durwalumabem i olaparybem (AZD2281), u pacjentek z nowo rozpoznanym, zaawansowanym rakiem jajnika
    A.3.2Name or abbreviated title of the trial where available
    DUO-O
    DUO-O
    A.4.1Sponsor's protocol code numberD081RC00001
    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 Clinical
    B.5.2Functional name of contact pointStudy Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone number18772409479
    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 Yes
    D.2.1.1.1Trade name IMFINZI
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 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.3.10 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: 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 Yes
    D.2.1.1.1Trade name Lynparza 100 mg film-coated Tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB SE-151 85 Södertälje Sweden
    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 nameolaparib 100 mg tablet
    D.3.2Product code AZD2281
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    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: 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 Yes
    D.2.1.1.1Trade name Lynparza 150 mg film-coated Tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    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 nameolaparib 150 mg tablet
    D.3.2Product code AZD2281
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Newly diagnosed advanced (FIGO stage III-IV) high grade epithelial ovarian, fallopian or primary peritoneal cancer
    Nowo rozpoznany (stopień zaawansowania III lub IV wg Federation Internationale de Gynecologie et d’Obstetrique [FIGO]) nabłonkowy rak jajnika, rak jajowodu lub pierwotny rak otrzewnej
    E.1.1.1Medical condition in easily understood language
    Advanced ovarian, fallopian or primary peritoneal cancer
    Zaawansowany rak jajnika, jajowodu lub pierwotny rak otrzewnej
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10016186
    E.1.2Term Fallopian tube cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10016187
    E.1.2Term Fallopian tube cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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
    To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of non-tBRCAm HRD positive patients and all non-tBRCAm patients with newly diagnosed advanced ovarian cancer.
    Określenie skuteczności durwalumabu i olaparybu wg oceny czasu przeżycia bez progresji choroby (PFS) w pierwszej linii leczenia pacjentek HRD pozytywnych bez tBRCAm oraz wszystkich pacjentek bez tBRCAm z nowo rozpoznanym zaawansowanym rakiem jajnika.
    E.2.2Secondary objectives of the trial
    - PFS in non-tBRCAm cohort
    - OS in non-tBRCAm HRD positive and all non-tBRCAm cohort,
    - ORR, ORR pre-surgery in IDS group, duration of response, PFS2, TFST, TSST and TDT in non-tBRCAm cohort
    - Health-related Quality of Life Outcomes (HRQoL), global health status and ovarian cancer symptoms in non-tBRCAm cohort
    - pCR in patients undergoing IDS in non-tBRCAm cohort
    - PK and Ig of durvalumab in sampling of population
    - PK of olaparib in sampling of population
    -the potential additional clinical benefit in tBRCAm cohort (PFS, PFS2, ORR, ORR pre-surgery in IDS group, duration of response, TFST, TSST, TDT, HRQoL, proportion of patients with pCR in patients undergoing IDS)
    •PFS w kohorcie bez tBRCAm
    •Przeżycie całkowite (OS) w kohorcie bez tBRCAm HRD pozytywnej oraz bez tBRCAm
    •ORR, ORR przed operacją chirurgiczną w grupie z odroczoną operacją cytoredukcyjna (IDS), czas trwania odpowiedzi (DoR), czas do pierwszej kolejnej terapii (TFST), czas do drugiej kolejnej terapii (TSST) i czas do przerwania leczenia lub zgonu (TDT) w kohorcie bez tBRCAm
    •Ocena HRQoL, ogólny stan zdrowia i objawy raka jajnika w grupie bez tBRCAm
    •Odpowiedź całkowita oceniana histopatologicznie (pCR) w grupie IDS w kohorcie bez tBRCAm
    •Charakterystyka farmakokinetyki i immunogenności durwalumabu na podstawie wybiórczo pobranych próbek do analiz populacyjnych
    •Farmakokoinetyka olaparybu ocena wybiórczo pobranych próbek do analiz populacyjnych
    •Ocena potencjalnych dodatkowych korzyści klinicznych (PFS, PFS2, ORR, ORR przed operacją chirurgiczną w grupie IDS, DoR, TFST, TSST, TDT, HRQoL, odsetek pacjentek z pCR wśród uczestniczek badania poddawanych IDS w kohorcie z tBRCAm.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serous, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer
    • Patients must be aged ≥18 years of age
    • All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
    • Mandatory provision of tumour sample for centralised tBRCA testing
    • Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
    • ECOG performance status 0-1
    • Patients must have preserved organ and bone marrow function
    • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test
    1. Pacjentki z nowo rozpoznanym, histologicznie potwierdzonym, zaawansowanym (stopień zaawansowania III lub IV wg Federation Internationale de Gynecologie et d’Obstetrique [FIGO]) nabłonkowym rakiem jajnika o wysokim stopniu złośliwości, w tym z rakiem surowiczym, rakiem endometrioidalnym, rakiem jasnokomórkowym jajnika lub mięsakorakiem jajnika, pierwotnym rakiem otrzewnej i/lub rakiem jajowodu;
    2. Pacjentki muszą mieć ≥18 lat;
    3. U wszystkich pacjentek musiała zostać przeprowadzona operacja pierwotna LUB musi być zaplanowana chemioterapia z odroczoną operacją cytoredukcyjną;
    4. Wymagana jest dostępność próbki guza do centralnie wykonywanego badania tBRCA;
    5. Potwierdzenie obecność/braku obecności mutacji BRCA1/2 w próbce guza;
    6. Stan sprawności (PS) wg Eastern Cooperative Oncology Group (ECOG) 0 lub 1;
    7. U pacjentek musi występować prawidłowa czynność narządów i szpiku kostnego;
    8. Kobiety po menopauzie lub stwierdzony status niezdolności do posiadania potomstwa: ujemny wynik testu ciążowego wykonanego przy użyciu próbki moczu lub surowicy.
    E.4Principal exclusion criteria
    • Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology
    • Prior systemic anti-cancer therapy for ovarian cancer
    • Prior treatment with PARP inhibitor or immune mediated therapy
    • Planned intraperitoneal cytotoxic chemotherapy
    • Active or prior documented autoimmune or inflammatory disorders
    • Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
    • Clinically significant cardiovascular disease
    • History of another primary malignancy except for
    - Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
    - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    - Adequately treated carcinoma in situ without evidence of disease
    - Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
    1. Nienabłonkowy rak jajnika, guzy graniczne, guzy nabłonkowe o niskim stopniu złośliwości lub typie histologicznym śluzowym;
    2. Wcześniejsze ogólnoustrojowe leczenie przeciwnowotworowe raka jajnika;
    3. Wcześniejsze leczenie inhibitorem PARP lub wcześniejsza ekspozycja na leczenie immunologiczne;
    4. Planowana cytotoksyczna chemioterapia dootrzewnowa;
    5. Udokumentowane aktywne lub wcześniej przebyte choroby autoimmunologiczne lub zapalne;
    6. Pacjentki uznane za należące do grupy podwyższonego ryzyka z powodu poważnej, niewyrównanej choroby współistniejącej;
    7. Klinicznie istotna choroba układu krążenia;
    8. Inny pierwotny nowotwór złośliwy w wywiadzie, z wyjątkiem:
    • Nowotworu złośliwego leczonego w przeszłości z zamiarem wyleczenia, bez danych wskazujących na aktywny proces nowotworowy w okresie >5 lat przed przyjęciem pierwszej dawki w dniu 1 cyklu 1 i przy niskim potencjalnym ryzyku nawrotu (pacjentki, które otrzymywały wcześniej chemioterapię adiuwantową z powodu raka piersi we wczesnym stadium mogą kwalifikować się do badania pod warunkiem ukończenia takiej chemioterapii >3 lata przed rejestracją, przy czym u pacjentki nie może występować nawrót ani przerzuty choroby)
    • -Prawidłowo leczonego nieczerniakowego raka skóry lub złośliwej plamy soczewicowatej bez cech obecności choroby
    • -Prawidłowo leczonego raka in situ bez cech obecności choroby
    • -Raka endometrium w stadium zaawansowania IA wg FIGO, stopień złośliwości 1 lub 2
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) is defined as the time from
    randomisation to the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the
    patient withdraws from assigned therapy or receives another anticancer therapy prior to progression.
    Czas przeżycia bez progresji choroby (PFS) jest definiowany jako czas od randomizacji do obiektywnie potwierdzonej progresji choroby lub zgonu (jakiegokolwiek powodu w przypadku niewystąpienia progresji) niezależnie od tego czy pacjentka zrezygnowała z przyjmowania przypisanego jej leczenia czy też przyjmowała leczenie przeciwnowotworowe przed odnotowaniem progresji.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiologic scans (assessed according to RECIST 1.1) performed from first patient enrolled to data cut off (approximately 52 months after first patient has received first dose of IP).
    Ocena radiologiczna (zgodnie z kryteriami RECIST 1.1.) będzie wykonywana od chwili włączenia pierwszego pacjenta do dnia odcięcia danych (ok. 52 miesięcy po podaniu dawki badanego produktu pierwszej pacjentce)
    E.5.2Secondary end point(s)
    Progression Free Survival (PFS)
    Overall Survival (OS)
    Second Progression (PFS2)
    Objective Response Rate (ORR)
    Duration of response (DoR)
    Time to first subsequent therapy (TFST)
    Time to second subsequent therapy (TSST)
    Time to discontinuation or death (TDT)
    Pathological complete response (pCR)
    Health related Quality of Life (HRQoL)
    Pharmacokinetic and Immunogenicity
    przeżycie bez progresji choroby (PFS)
    przeżycie całkowite (OS)
    czas do drugiej progresji (PFS2)
    odsetek odpowiedzi obiektywnych (ORR)
    czas trwania odpowiedzi (DoR)
    czas do pierwszej kolejnej terapii (TFST)
    czas do drugiej kolejnej terapii (TSST)
    czas do przerwania leczenia lub zgonu (TDT)
    odpowiedź całkowita oceniana histopatologicznie (pCR)
    kwestionariusz dotyczący jakości życia (HRQoL)
    farmakokinetyka i immunogenność
    E.5.2.1Timepoint(s) of evaluation of this end point
    From first patient enrolled to data cut off (approximately 52 months
    after first patient has received first dose of IP).
    A final analysis of OS, TFST, TSST, TDT will be performed at
    approximately 5 years following the randomisation of the last non
    tBRCAm patient.
    Od włączenia pierwszego pacjenta do daty odcięcia danych (około 52 miesiące po podaniu pierwszemu pacjentowi pierwszej dawki badanego produktu leczniczego).
    Analiza końcowa OS, TFST, TSST, TDT zostanie przeprowadzone po około 5 latach od randomizacji ostatniego pacjenta bez tBRCAm.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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
    Kohorta bez tBRCA powójnie zaślepione leczenie i kohorta z tBRCAm pojedyncza grupa leczenie otwarte
    in addition to double blinded non-tBRCA cohort, there is a single open label tBRCAm cohort
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA147
    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
    Peru
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Spain
    Türkiye
    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 study is defined as the data cut-off point for the final analysis of OS in the non-tBRCAm cohort (at approximately 50% maturity or 5 years after the last non-tBRCAm patient is randomised to treatment, whichever occurs sooner).
    Zakończenie badania zdefiniowano, jako punkt odcięcia danych dla końcowej analizy OS w kohorcie bez tBRCA (przy zakładanej kompletności ok. 50% lub 5 lat po losowym przydzieleniu leczenia ostatniej pacjentce bez tBRCAm, którekolwiek nastąpi to wcześniej).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 1168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 206
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 827
    F.4.2.2In the whole clinical trial 1374
    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)
    Patient will receive treatment in accordance with standard local clinical practice.
    Pacjentki będą otrzymywały leczenie zgodnie z lokalnymi standardami i praktyką kliniczną.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AGO Research GmbH
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation GOG Foundation, Inc.
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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