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    Summary
    EudraCT Number:2013-001211-75
    Sponsor's Protocol Code Number:D0816C00002
    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:2013-09-09
    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 number2013-001211-75
    A.3Full title of the trial
    A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy
    Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo, wieloośrodkowe badanie fazy III oceniające leczenie podtrzymujące z zastosowaniem olaparibu w monoterapii u pacjentek z wrażliwym na pochodne platyny, nawrotowym rakiem jajnika z mutacją BRCA, u których utrzymuje się odpowiedź całkowita lub częściowa po chemioterapii opartej na pochodnych platyny
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib treatment in BRCA Mutated Ovarian Cancer patients after Complete or Partial Response to Platinum Chemotherapy
    Leczenie olaparibem pacjentek z rakiem jajnika i mutacją BRCA, u których utrzymuje się odpowiedź całkowita lub częściowa po chemioterapii opartej na pochodnych platyny
    A.3.2Name or abbreviated title of the trial where available
    SOLO2
    SOLO2
    A.4.1Sponsor's protocol code numberD0816C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01874353
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/501
    D.3 Description of the IMP
    D.3.1Product nameOlaparib
    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: 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/501
    D.3 Description of the IMP
    D.3.1Product nameOlaparib
    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
    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
    BRCA Mutated Platinum Sensitive Relapse (PSR) high grade Serous Ovarian Cancer
    wrażliwy na pochodne platyny nawrotowy (PSR) surowiczy rak jajnika o wysokim stopniu złośliwości z mutacją BRCA
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    rak jajnika
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    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 10061269
    E.1.2Term Malignant peritoneal neoplasm
    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 PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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
    Determine the efficacy by progression free survival of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
    Określenie skuteczności, na podstawie czasu przeżycia bez progresji choroby (PFS) leczenia podtrzymującego z zastosowaniem olaparibu w monoterapii w porównaniu z placebo u pacjentek z nawrotowym rakiem jajnika z mutacją BRCA, u których utrzymuje się odpowiedź całkowita lub częściowa po chemioterapii opartej na pochodnych platyny
    E.2.2Secondary objectives of the trial
    1. Efficacy in patients following Platinum Based Chemotherapy by assessment of overall survival
    2. Efficacy in patients following Platinum Based Chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen (CA-125)
    3. Efficacy in patients following Platinum Based Chemotherapy by assessment of time to earliest progression by RECIST or Efficacy in patients following Platinum Based Chemotherapy by assessment of time from randomisation to second progression
    4. Health-Related Quality of Life (HRQoL) as assessed by TOI and FACT-O
    5. Efficacy in patients with a deleterious or suspected deleterious variant in either of the BRCA genes by assessment of PFS.
    6. To determine the exposure to Olaparib
    7. Safety and tolerability of olaparib by assessment of the number of AEs and review of laboratory parameters
    Określenie skuteczności u pacjentek po chemioterapii opartej na pochodnych platyny:
    1.na podstawie oceny całkowitego czasu przeżycia
    2.na podstawie oceny czasu do wystąpienia najwcześniejszej progresji choroby według kryteriów RECIST lub progresja poziomu antygenu CA-125
    3.na podstawie oceny czasu do wystąpienia najwcześniejszej progresji według RECIST lub określenie skuteczności u pacjentek po chemioterapii opartej na pochodnych platyny na podstawie oceny czasu od randomizacji do 2.progresji
    4.Ocena jakości życia uwarunkowanej stanem zdrowia (HRQoL) na podstawie oceny wskaźnika wyników badania (TOI) kwestionariusza FACT-O
    5.Ocena skuteczności w podgrupie pacjentek, u których stwierdzono szkodliwy lub podejrzewany o szkodliwość wariant któregokolwiek z genów BRCA na podstawie PFS
    6.Określenie ekspozycji na olaparib
    7.Bezpieczeństwo i tolerancja leczenia na podstawie oceny liczby zdarzeń niepożądanych i przeglądu danych laboratoryjnych.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must be ≥ 18 years of age.
    • Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
    • Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss
    of function).
    • Patients who have received at least 2 previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study:
    • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study:
    • Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
    • Patient must have received a platinum based chemotherapy regimen (eg. carboplatin or cisplatin) and have received at least 4 cycles of treatment
    1.Pacjentki muszą być w wieku co najmniej 18 lat
    2.Kobiety z rozpoznanym histologicznie, nawrotowym surowiczym rakiem jajnika o wysokim stopniu złośliwości (w tym pierwotnym rakiem otrzewnej i/lub rakiem jajowodu) bądź rakiem endometrium o wysokim stopniu złośliwości
    3.Udokumentowana mutacja genu BRCA1 lub BRCA2, co do której przewiduje się, że jest szkodliwa lub podejrzewa się szkodliwość (o której wiadomo lub co do której przewiduje się, że jest szkodliwa/prowadzi do utraty funkcji).
    4.Pacjentki, które otrzymały wcześniej co najmniej 2 linie leczenia opartego na pochodnych platyny przed randomizacją:
    a.W odniesieniu do przedostatniego kursu chemioterapii przed włączeniem do tego badania:
    i.Po tym leczeniu u pacjentki musi zostać stwierdzona wrażliwość na pochodne platyny, co jest zdefiniowane jako czas do wystąpienia progresji choroby wynoszący więcej niż 6 miesięcy po otrzymaniu ostatniej dawki chemioterapii obejmującej pochodną platyny
    b.W odniesieniu do ostatniego kursu chemioterapii, stosowanego bezpośrednio przed randomizacją w ramach tego badania:
    i.W opinii badacza u pacjentki musi występować odpowiedź (częściowa lub całkowita odpowiedź radiologiczna) albo nie mogą występować oznaki choroby (w przypadku wykonania optymalnej operacji cytoredukcyjnej przed chemioterapią), a ponadto nie mogą występować oznaki podwyższenia poziomu CA-125, po zakończeniu tego kursu chemioterapii.
    ii.Pacjentka musi otrzymywać schemat chemioterapii oparty na pochodnej platyny (karboplatynie lub cisplatynie) i musi otrzymać co najmniej 4 cykle leczenia.
    E.4Principal exclusion criteria
    • Involvement in the planning and/or conduct of the study (applies to
    both AstraZeneca staff and/or staff at the study site).
    • BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., “Variants of uncertain clinical significance” or “Variant of unknown significance” or “Variant, favour polymorphism” or “benign polymorphism” etc.)
    • Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
    1.Udział w planowaniu i/lub prowadzeniu badania (dotyczy personelu firmy AstraZeneca i/lub personelu ośrodka badawczego).
    2.Mutacje BRCA1 i/lub BRCA2, które są uważane za nieszkodliwe (np. „Warianty o niepewnym znaczeniu klinicznym” lub „Wariant o nieznanym znaczeniu” lub „Wariant, korzystny polimorfizm” lub „łagodny polimorfizm” itp.).
    3.Pacjentki, u których wykonano drenaż ropnia w okresie ostatnich 2 cykli ostatniego schematu chemioterapii przed włączeniem do badania.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) by investigator review of RECIST data.
    Czas przeżycia bez progresji choroby (PFS) w centralnej ocenie danych RECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiologic scans performed at base line then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression.
    Study data collection expected to last until 2018.
    Badanie radiologiczne będzie wykonywane podczas wizyty wejściowej (dane wyjściowe) oraz co 12 tygodni (±1 tydzień) do tygodnia 72, a następnie, co 24 tygodnie (±1 tydzień), do czasu wystąpienia obiektywnej radiologicznej progresji choroby.
    Przewiduje się, że okres zbierania danych będzie trwał do 2018 roku.
    E.5.2Secondary end point(s)
    1. Efficacy in patients following Platinum Based Chemotherapy by assessment of overall survival
    2. Efficacy in patients following Platinum Based Chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen (CA-125) or death
    3. Efficacy in patients following Platinum Based Chemotherapy by assessment of time from randomisation to second progression
    4. Health-Related Quality of Life (HRQoL) as assessed by TOI and FACT-O
    5. Efficacy in patients with a deleterious or suspected deleterious variant in either of the BRCA genes by assessment of PFS.
    6. To determine the exposure to Olaparib by Pharmacokinetic analysis
    7. Safety and tolerability of olaparib by assessment of the number of AEs and review of laboratory parameters
    8. Efficacy of olaparib by time to first subsequent therapy or death (TFST)
    9. Efficacy of olaparib by time to second subsequent therapy or death (TSST)
    10. Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT)
    1.Określenie skuteczności u pacjentek po chemioterapii opartej na pochodnych platyny, na podstawie oceny całkowitego czasu przeżycia
    2.Określenie skuteczności u pacjentek po chemioterapii opartej na pochodnych platyny, na podstawie oceny czasu do wystąpienia najwcześniejszej progresji stwierdzonej na podstawie kryteriów RECIST lub poziomu CA-125, bądź do wystąpienia zgonu
    3.Określenie skuteczności u pacjentek po chemioterapii opartej na pochodnych platyny, na podstawie oceny czasu od randomizacji do wystąpienia drugiej progresji choroby (PFS2)
    4.Ocena jakości życia uwarunkowanej stanem zdrowia (HRQoL) na podstawie oceny wskaźnika wyników badania (TOI) kwestionariusza oceny czynnościowej leczenia raka jajnika (FACT-O)
    5.Skuteczność olaparibu w podgrupie pacjentek, u których stwierdzono szkodliwy lub podejrzewany o szkodliwość wariant któregokolwiek z genów BRCA na podstawie czasu przeżycia bez progresji choroby (PFS)
    6.Ocena ekspozycji na olaparib
    7.Bezpieczeństwo i tolerancja leczenia olaparibem w oparciu o liczbę zdarzeń niepożądanych i dane z wyników badań laboratoryjnych
    8.Czas do (włączenia) pierwszej kolejnej terapii lub zgonu (TFST)
    9.Czas do (włączenia) drugiej kolejnej terapii lub zgonu (TSST)
    10.Czas do przerwania leczenia lub zgonu (TDT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data collection until 2018, except Pk endpt 6
    1)Survival assessed 4 wkly until treatment discont, then 12 wkly
    2)CA-125, baseline 4 wkly. Radiological scans, baseline, ~12 wkly until obj radiologic disease prog
    3)Radiologic scans, baseline, 12 wkly for 72 wks, 24 wkly until 1st prog. As per local practice until 2nd prog
    4)Paper Q's baseline, Day 29 then as per RECIST, until disease prog
    5)Radiologic scans baseline, ~12 wkly for 1st 72 wks, ~24 wkly, until disease prog
    6)Pk in subset of patients. Samples: Day 1+15 pre & 1 hr; Day 29 pre,0.5-1,1-3,3-6 and 6-12hrs
    7.AEs from IC until post treatment 30-day follow-up. Labs until treatment discont
    Randomisation to:8)1st therapy or death9)2nd therapy or
    death10)discont or death. Assessed at 1ary PFS + final OS, data collection for ~7yrs
    Dane zbierane, poza poz. nr 6 (PK), do 2018 r.
    1.Całk. czas przeż.: co 4 tyg. do przerw. lecz., co 12 tyg.
    2.CA-125: wyjś., co 4 tyg. Bad. radiol.: wyjś, co ~12 tyg. do ob. radiol. progr.
    3.Bad. radiol.: wyjś, co 12 tyg.przez 72 tyg., co 24 tyg. do 1.progresji. Wg lok. praktyki do 2.progr.
    4.Kwestion.: na wizycie wyejś, w dniu 29, zgodnie z RECIST do progr.
    5.Bad. radiol.: wyjś, co ~12 tyg. przez 72 tyg., co ~24 tyg. do progr. choroby
    6.PK - podgrupa, Schemat: Dzień 1 i 15: przed i 1 godz. po pod.; Dzień 29: przed i po pod., odp. 0,5-1 godz., 1-3 i 6-12 godz.
    7.AE – na bieżąco; 30-dni obs. po lecz.; laborat. - do przerw. leczenia
    Od rand do 8. 1-kol. terapii/zgonu 9) 2-kol. terapii/zgonu 10) do przerw. leczenia/zgonu. Ocena: pierw. PFS + fin. analizy OS. Dane zbierane ~7 lat.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Brazil
    Canada
    China
    France
    Germany
    Italy
    Japan
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    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
    LVLS (last visit last subject) undergoing the study
    LVLS (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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: 147
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 294
    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)
    Patients who are receiving treatment can either choose to discontinue from the study, or where the investigator believes the patients are gaining clinical benefit, patients may continue to recieve study treatment.
    Pacjentki otrzymujące badane leczenie będą mogły wybrać opcję wycofania z badania lub, jeśli w opinii Badacza pacjentki odnoszą korzyść kliniczną z terapii, mogą kontynuować badane leczenie.
    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 ARCAGY-GINECO, acting as lead group for ENGOT
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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