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    Summary
    EudraCT Number:2012-003547-29
    Sponsor's Protocol Code Number:04-22
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-25
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-003547-29
    A.3Full title of the trial
    A Phase III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer
    Fázis III, többközpontú, randomizált, kontrollált vizsgálat az önmagában és az ON 01910.Na-mal együtt adott gemcitabin hatékonyságának és biztonságosságának összehasonlítására kezeletlen, áttétes hasnyálmirigyrákos betegeknél.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of ON 01910.Na in combination with Gemcitabine vs. Gemcitabine alone in patients with a previously untreated metastatic pancreatic cancer.
    Az önmagában és az ON 01910.Na-mal együtt adott gemcitabin hatékonyságának és biztonságosságának összehasonlítására irányiuló vizsgálat kezeletlen, áttétes hasnyálmirigyrákos betegeknél. Fázis II/III, többközpontú, randomizált, kontrollált vizsgálat.
    A.3.2Name or abbreviated title of the trial where available
    AGICC 11PAN01
    A.4.1Sponsor's protocol code number04-22
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01360853
    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 SponsorOnconova Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportOnconova Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI CROHungary Pharma Support LLc
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSzabadság tér 7, Platina torony, 3 em
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post codeH-1054
    B.5.3.4CountryHungary
    B.5.4Telephone number+36 15556755
    B.5.5Fax number+3615556750
    B.5.6E-mailRABudapest@psi-cro.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 namerigosertib sodium
    D.3.2Product code ON 01910.Na
    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 INNrigosertib
    D.3.9.1CAS number 592542-60-1
    D.3.9.2Current sponsor codeON 01910.Na
    D.3.9.3Other descriptive namerigosertib sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 2
    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 N/A
    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 namegemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Pancreatic Cancer
    Áttétes hasnyálmirigyrák
    E.1.1.1Medical condition in easily understood language
    Advanced pancreatic cancer
    Előrehaladott hasnyálmirigyrák
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    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
    The primary objective of the study is to compare overall survival in chemotherapy-naive patients with metastatic pancreatic cancer receiving gemcitabine 1000 mg/m2 weekly combined with ON 01910.Na at 1800 mg/m2 via 2-hour continuous intravenous infusions administered twice weekly for 3 weeks of a 4-week cycle vs. gemcitabine alone at 1000 mg/m2 weekly for 3 weeks of a 4-week cycle.
    A teljes túlélés összehasonlítása (overall survival = OS) kemoterápiát még nem kapott áttétes hasnyálmirigyrákos betegeknél, ha kezelésük heti 1000 mg/m2 gemcitabin és heti két 1800 mg/m2 adagú rigosertib kétórás folyamatos infúzió (CIV) kombinációjával történik a 4 hetes ciklus 3 hetében, illetve, ha csak gemcitabint kapnak heti 1000 mg/m2 adagban a 4 hetes ciklus 3 hetében.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the gemcitabine + ON 01910.Na group to the gemcitabine-only group with respect to:
    -Progression-free survival time
    -Objective response rates using Response Evaluation Criteria In Solid Tumors (RECIST)
    -Safety/tolerability
    -Quality of life (QOL)
    Additional secondary objectives include:
    -ON 01910.Na population pharmacokinetics (combined treatment group only)
    -Full ON 01910.Na and gemcitabine pharmacokinetics in a subset of 10 patients in the combined treatment group only
    -Biomarker analysis (to include markers of the PI3K/AKT and PLK1 pathways) performed on archival tissue from all patients; results will be correlated with efficacy outcomes.
    • A gemcitabin + rigosertib csoport összehasonlítása a csak gemcitabin csoporttal a következő szempontok szerint-:
    -Progressziómentes túlélés (PFS)
    -Objektív válasz arány a RECIST skála (Response Evaluation Criteria in Solid Tumors) alapján
    -Biztonságosság/tolerálhatóság
    -Életminőség (QOL)
    •A következők értékelése:
    -Rigosertib populációban farmakokinetika (csak a kombinált kezelésben részesülőknél)
    -Teljes rigosertib és gemcitabin farmakokinetika, kizárólag a kombinált kezelésben részesülők egy 10 fős alcsoportjában (Az 1. módosítás szerint)
    -Biomarkerek (beleértve a PI3K/AKT és a PLK1 út biomarkereit), amit az összes betegtől származó tárolt szövetmintákon végzünk, és az elért hatékonysággal vetünk össze.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Fresh Biopsy Substudy
    Fresh tumor biopsies may be obtained in a subpopulation of up to 25 patients in order to permit molecular analysis of tumor tissue obtained just prior to treatment, as well as tumor tissue obtained under highly controlled circumstances permitting the analysis of messenger ribonucleic acid (mRNA).
    Pharmacokinetics
    Blood samples for measurement of ON 01910.Na will be taken in Cycle 1 in all patients in Arm A at pre-dose, 1 hour after starting the ON 01910.Na infusion, and just before the end of ON 01910.Na infusion on Day 1 and Day 15 for population pharmacokinetics.
    At a limited number of sites, blood samples for measurement of ON 01910.Na and gemcitabine will be obtained at Cycle 1 Day 1 only, in a subset of 10 patients in Arm A
    E.3Principal inclusion criteria
    1. Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes;
    2. Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy;
    3. Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD)≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥ 15 mm in the short axis;
    4. ECOG Performance Status of 0, 1, or 2 (see Appendix 1);
    5. Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL, with a minimum calculated glomerular filtration rate (GFR) of 40 mL/min (Cockcroft-Gault method);
    6. Patients must have adequate liver function as defined by total bilirubin ≤ 2.0 mg/dL and transaminase levels no higher than 3.0 times the institution’s upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN;
    7. All patients must have a serum albumin ≥ 3.0 g/dL;
    8. Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥ 1,500/mm3, a platelet count ≥ 100,000/mm3, and hemoglobin >9 g/dL;
    9. Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease);
    10. Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients. Male patients with female partners with reproductive potential will utilize birth control methods (e.g., condom use) while participating in this trial;
    11. Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin (βHCG) pregnancy test at Screening;
    12. Willing to adhere to the prohibitions and restrictions specified in this protocol;
    13. Patient must have signed an informed consent document.
    1.Legalább 18 éves férfi, vagy nőbeteg, akinek kórszövettani, vagy citológiai lelettel bizonyíthatóan áttétes hasnyálmirigy adenokarcinómája van. Áttétnek tekinthető, ha a betegség túlterjedt a peri-pankreatikus nyirokcsomókon, amint az az 1. módosításban szerepel;
    2.Kórtörténetben nem szerepel korábbi kemoterápia beleértve az adjuváns kemoterápiát is a hasnyálmirigyrák kezelésére (lásd az 1. módosítást);
    3.A betegség mérhető, azaz olyan léziók láthatóak, amelyeknek legalább egyik dimenzióját pontosan meg lehet adni leghosszabb ármérőjével (LD), ami hagyományos technikával mérve ≥20 mm, spirál CT módszerrel mérve pedig ≥10 mm, a mérhető nyirokcsomó rövid tengelye pedig ≥15 mm (lásd az 1. módosítást).;
    4.ECOG érték 0, 1, vagy 2;
    5.Megfelelő vesefunkció és szérum kreatinin szint ≤2.0 mg/dl, illetve a Cockroft-Gault formula szerint számított glomerulus filtrációs ráta (GFR) legalább 40 ml/min (lásd a 2. módosítást);
    6.Megfelelő májfunkció, amit jelez, hogy a teljes bilirubin ≤2.0 mg/dl illetve a transzamináz szintek nem haladják meg a normál érték felső határának a háromszorosát. A májáttétes betegek transzamináz szintje a felső érték (ULN) 5.0-szöröse lehet.;
    7.Szérum albumin ≥3.0 g/dL;
    8.Megfelelő csontvelő (BM) funkció, amit a granulocita ≥1,500/mm3, trombocita ≥100,000/mm3, valamint a hemoglobin>9 g/dl érték igazol.
    9.Több mint 5 éves betegségmentes időszak egy esetleges korábbi, de nem hasnyálmirigy eredetű rák után (kivéve a kuratívan kezelt bazálsejtes karcinóma, a bőr laphámsejtes rákja, az in situ méhnyak rák, valamint a duktális in situ emlő karcinóma (DCIS);
    10.Megbízható fogamzásgátló módszerek alkalmazása (ideértve a receptköteles, szájon át szedett fogamzásgátlókat [a tabletta], a fogamzásgátló injekciókat, a méhen belüli eszközt [IUD], a kettős barrier módszert [spermicid gél, vagy hab kondommal, vagy pesszáriummal], a fogamzásgátló tapaszt , vagy a műtéti sterilizálást) a vizsgálatba való belépés előtt, és végig a vizsgálat alatt, ha a vizsgálati alany fogamzóképes nőbeteg, vagy a férfi beteg partnere az (a 2. módosítás szerint);
    11.Vizeletből végzett negatív βHCG (humán koriogonadotropin) terhességi teszt a szűréskor fogamzóképes korú nőbetegeknél;
    12.Együttműködési készség arra, hogy a beteg betartja vizsgálati tervben szereplő korlátozásokat és tilalmakat és aláírja a Betegtájékoztatót és a Beleegyező nyilatkozatot;
    13.A beteg aláírta a Beleegyező nyilatkozatot.
    E.4Principal exclusion criteria
    1. Patients with unresectable locally advanced disease without evidence of disease elsewhere;
    2. Life expectancy of less than 12 weeks;
    3. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or seizure disorder;
    4. Active infection not adequately responding to appropriate therapy;
    5. Symptomatic or clinically evident ascites;
    6. Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia (e.g., previous syndrome of inappropriate antidiuretic hormone hypersecretion [SIADH], chronic diuretic use, etc.)
    7. Female patients who are pregnant or lactating;
    8. Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start;
    9. Evidence of brain metastases. A CT scan or magnetic resonance imaging (MRI) of the brain should be obtained in patients with symptoms suggestive of brain metastases;
    10. Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of radiotherapy, or immunotherapy;
    11. Psychiatric illness/social situations that would limit the patient’s ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.).
    1.Operálhatatlan, lokálisan előrehaladott betegség, áttét nélkül;
    2.Várható élettartam <12 hét;
    3.Kezeletlen, időszakosan megjelenő betegség, például szimptomatikus kongesztív szívelégtelenség, instabil angina pectoris, aritmia, kezeletlen (1. módosítás) magas vérnyomás, vagy epilepszia;
    4.Megfelelő terápiára nem megfelelően reagáló aktív fertőzés;
    5.Szimptomatikus, vagy klinikailag igazolt ascites;
    6.A szérum nátrium <130 mEq/l, vagy olyan állapot, amely hyponatremiát valószínűsít (pl. Schwartz-Bartter szindróma [SIADH], krónikus vízhajtó használat, stb.), a 2. módosítás szerint;
    7.Terhesség, szoptatás;
    8. Nagyobb műtét, amely még nem teljesen gyógyult, vagy amelyet a rigosertib alkalmazását megelőző 3 héten belül végeztek;
    9.Bizonyított agyi metasztázis (az 1. módosítás szerint); CT, vagy MRI felvételt (mágneses rezonanciás képet) kell készíteni az agyról, ha a betegnek agyi metasztázisra utaló tünetei vannak (2. módosítás);
    10.Bármely a vizsgálati készítménnyel egyidejűleg, és/vagy a készítmény első adagját megelőző 4 hétben alkalmazott sugárterápia, vagy immunterápia;
    11.Olyan pszichés betegség/szociális helyzet, amely korlátozhatja a beteg tűrőképességét és/vagy a vizsgálati terv előírásainak betartását, vagy a beteg nem képes betartani a vizsgálati előírásokat, és/vagy az utánkövetéses előírásokat (pl. drogfüggőség, együttműködés teljes hiánya).
    E.5 End points
    E.5.1Primary end point(s)
    OS in the rigosertib + gemcitabine arm (Arm A) vs. gemcitabine-only arm (Arm B).
    teljes túlélés rigosertib + gemcitabine kar (Arm A) vs. csak gemcitabine kar (Arm B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of OS at the end of the trial will use the p-value as determined by Wassmer’s method
    Az OS elsődleges elemzése a vizsgálat végén a p értékeket használja majd, amint azok a Wassmer módszerben meg vannak határozva
    E.5.2Secondary end point(s)
    Progression-Free Survival and objective response
    a PFS és az objektív válasz
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-free survival is defined as the time from the randomization to documented disease progression or death.
    A progressziómentes túlélés a meghatározás szerint a randomizálástól a betegség dokumentált progressziójáig, illetve az elhalálozásig eltelt idő.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Hungary
    India
    Romania
    Russian Federation
    Ukraine
    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
    Until progression or until death from any cause, whichever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 346
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 364
    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)
    None
    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 Decision2012-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-02-27
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