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    Summary
    EudraCT Number:2014-002189-64
    Sponsor's Protocol Code Number:ALDOXORUBICIN-P2-SCLC-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-002189-64
    A.3Full title of the trial
    A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects with Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
    Multicentrikus, randomizált, nyílt, Fázis IIb vizsgálat az Aldoxorubicin és a Topotecan hatékonyságának és biztonságosságának összehasonlítására olyan metasztázisos, kissejtes tűdőrákos betegeknél, akik az első kemoterápiára nem reagáltak, vagy a kemoterápia után visszaestek.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare how safe Aldoxorubicin is and how well it works against Topotecan in patients with Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
    Vizsgálat az Aldoxorubicin és a Topotecan hatékonyságának és biztonságosságának összehasonlítására olyan metasztázisos, kissejtes tűdőrákos betegeknél, akik az első kemoterápiára nem reagáltak, vagy a kemoterápia után visszaestek.
    A.4.1Sponsor's protocol code numberALDOXORUBICIN-P2-SCLC-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02200757
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:75,478
    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 SponsorCytRx Corporation
    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 supportCytRx Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytRx Corporation
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address11726 San Vicente Boulevard, Suite 650
    B.5.3.2Town/ cityLos Angeles, California
    B.5.3.3Post code90049
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1310826-5648
    B.5.5Fax number+1310826-2472
    B.5.6E-mailclinical@cytrx.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 nameAldoxorubicin
    D.3.2Product code INNO-206
    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 INNaldoxorubicin
    D.3.9.2Current sponsor codealdoxorubicin
    D.3.9.3Other descriptive nameINNO-206
    D.3.9.4EV Substance CodeSUB34537
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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.2.5The 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 nameTopotecan 4 mg/4 ml
    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 INNTOPOTECAN
    D.3.9.1CAS number 123948-87-8
    D.3.9.4EV Substance CodeSUB11191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Small Cell Lung Cancer
    Metasztázisos, kissejtes tűdőrák
    E.1.1.1Medical condition in easily understood language
    Metastatic Lung Cancer
    Metasztázisos tűdőrák
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10059514
    E.1.2Term Small cell lung cancer metastatic
    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
    The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer (SCLC) who have relapsed or were refractory to prior chemotherapy, as measured by progression-free survival (PFS).
    A vizsgálat elsődleges célja, hogy a progressziómentes túlélés (PFS) paraméterei alapján meghatározzuk az aldoxorubicin alkalmazásának hatékonyságát a topotecannal összevetve olyan kissejtes tüdőrákos (SCLC) betegeknél, akik előzőleg nem reagáltak a kemoterápiára, vagy a kemoterápia után visszaestek
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the efficacy of aldoxorubicin as measured by overall survival (OS), safety of aldoxorubicin compared to topotecan in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.
    A vizsgálat másodlagos célkitűzései között szerepel az aldoxorubicin hatékonyságának mérése a teljes túlélés (OS) szempontjából, az aldoxorubicin biztonságossága a vizsgált csoportban a topotecannal összehasonlítva, aszerint, hogy mennyire gyakoriak és súlyosak a nemkívánatos események (AE), milyen rendellenességek adódnak a fizikális vizsgálat, a laborvizsgálat, az életfunkciós jelek és testsúly mérése során, valamint az echokardiogram (ECHO) és elektrokardiogram (EKG) értékelése során, továbbá milyen a betegség kontroll aránya (DCR) és hogyan változik a daganat.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years male or female.
    2. Histological confirmation of SCLC.
    3. Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable
    by either surgery or radiation.
    4. Capable of providing informed consent and complying with trial procedures.
    5. ECOG PS 0-2.
    6. Life expectancy >8 weeks.
    7. Measurable tumor lesions according to RECIST 1.1 criteria.
    8. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
    9. Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
    10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
    11. Accessibility to the site that ensures the subject will be able to keep all study-related appointments.
    1.18 éves, vagy idősebb férfi és nőbeteg.
    2.Szövettannal igazolt SCLC.
    3.Nem reagált, vagy visszaeséssel reagált legfeljebb 1 korábbi szisztémás terápiás kezelésre, és sem műtéttel, sem sugárterápiával nem gyógyítható.
    4.Képes informált tájékoztatáson alapulva beleegyező nyilatkozatot adni és eleget tenni a vizsgálati eljárásoknak.
    5.ECOG státusz 0-2.
    6.Várható élettartam >8 hét.
    7.A RECIST 1.1 kritériumok szerint mérhető tumor léziók.
    8.A nők nem lehetnek fogamzóképesek a vizsgálat idején, azaz már legalább 1 éve menopauzában vannak, műtéti sterilizáláson estek át, vagy megfelelő fogamzásgátlást alkalmaznak. Megfelelő fogamzásgátlás lehet a szájon át szedett tabletta, a beültetett fogamzásgátló, a már legalább 3 hónappal korábban felhelyezett méhen belüli eszköz, vagy barrier módszer spermiciddel kiegészítve.
    9.A férfiak és fogamzóképes partnereik kétféle elfogadott fogamzásgátlási módszert kötelesek alkalmazni (lásd a fenti, 8. pontot plusz vagy kondomot, vagy férfiaknál a vazektómiát) a hölgypartner utolsó menstruációjától a kezelés teljes időtartama alatt, és a vizsgálati készítmény utolsó dózisától számított még további 6 hónapon át.
    10.A fogamzóképes nők szérumból, vagy vizeletből kimutatott terhességi tesztjének negatívnak kell lennie a szűréskor, és nem szoptathatnak.
    11.A vizsgálati helynek elérhető távolságban kell lennie, hogy a vizsgálati alanyok be tudják tartani a vizsgálattal kapcsolatos vizitek időpontját.
    E.4Principal exclusion criteria
    1. Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
    2. Prior treatment with topotecan.
    3. Palliative surgery and/or radiation treatment < 14 days prior to date of randomization.
    4. Exposure to any investigational agent within 30 days of date of randomization.
    5. Exposure to any systemic chemotherapy within 21 days of date of randomization.
    6. Active (symptomatic) central nervous system (CNS) metastasis.
    7. History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.
    8. Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.
    9. Anion gap >16 meq/L or arterial blood pH <7.30
    10. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
    11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
    12. Baseline QTc >470 msec measured by Fridericia’s formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
    13. History or signs of active coronary artery disease with angina pectoris within the last 6 months.
    14. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution’s lower limit of predicted normal.
    15. Known history of HIV infection.
    16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or antifungals.
    17. Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
    18. Major surgery within 30 days prior to date of randomization.
    19. Substance abuse or any condition that might interfere with the subject’s participation in the study or in the evaluation of the study results.
    20. Any condition that is unstable and could jeopardize the subject’s participation in the study.
    1.Korábban >375 mg/m2 doxorubicint, vagy liposzómás doxorubicint kapott.
    2.Korábban kezelték már topotecannal.
    3.Palliatív műtéte és/vagy sugárterápiás kezelése volt a randomizálás előtti 14 napban.
    4.Vizsgálati készítménnyel kezelték a randomizálást megelőző 30 napban.
    5.Szisztémás kemoterápiás kezelést kapott a randomizálást megelőző 21 napban.
    6.Aktív (szimptomatikus) központi idegrendszeri (CNS) metasztázis.
    7.Kórtörténetben más rosszindulatú elváltozások is szerepelnek, kivéve a gyógyult bazálsejtes karcinómát, a laphámrákot, az in situ melanomát, a felszíni hólyagrákot, vagy a méhnyak in situ karcinómáját, amennyiben azt már legalább 3 éve igazoltan gyógyultnak lehet tekinteni.
    8.Laborértékek: szérum kreatinin a szűréskor a normál érték felső határának (ULN) >1.5×, alanin aminotranszferáz (ALT) >3×ULN vagy májmetasztázis esetében >5×ULN, összbilirubin >2×ULN, abszolút neutrofil szám (ANC) <1,500/mm3, vérlemezke koncentráció <100,000/mm3, hemoglobin <9 g/dl, albumin <2 gm/dl.
    9. Anionhiány >16 meq / l vagy artériás vér pH <7,30
    10. Klinikailag bizonyított pangásos szívelégtelenség, (CHF) amely a New York Heart Association (NYHA) beosztás szerint >II .
    11. Jelenleg fennálló, súlyos, klinikailag szignifikáns szívaritmiák, amelybe vagy az abszolút aritmiák, vagy a Lown III, IV vagy V osztályú kamrai aritmiák tartoznak.
    12. Alap QTc >470 msec a Fridericia képlettel mérve (QTcF) és/vagy a QT megnyúlása a kórtörténetben más gyógyszerek szedése kapcsán. Nem szabad egyidejűleg olyan készítményt szedni, amelynél magas a QT idő megnyúlásának incidenciája.
    13. Jelenlegi, vagy az elmúlt 6 hónapon belüli aktív koronária megbetegedés jelei angina pectorissal.
    14. Súlyos myocardiális funkciózavar; a bal kamrai ejekciós frakció (LVEF) az ECHO vizsgálat alapján az intézményi normál érték alsó határa alatt van.
    15. Ismert HIV fertőzés a kórtörténetben.
    16. Aktív, klinikailag szignifikáns súlyos fertőzés, amely antibiotikumos, antivirális, vagy antifungális kezelést tesz szükségessé.
    17. P-glycoprotein inhibitorral, például cyclosporin A-val elacridarral, ketoconazollal, ritonavirral, vagy saquinavirral történő kezelés.
    18. A randomizálást megelőző 30 napon belül nagyműtét.
    19. Élvezeti szerekkel való visszaélés, vagy bármi más betegség, amely veszélyeztethetné a vizsgálati alany részvételét a vizsgálatban, vagy a vizsgálati eredmények értékelésében.
    20. Bármely instabil egészségi állapot, amely veszélyeztetné a vizsgálati alany részvételét a vizsgálatban.
    E.5 End points
    E.5.1Primary end point(s)
     PFS
     OS
     Objective tumor response (RECIST 1.1 criteria).
     Disease control rate (ORR + SD at 4 months).
     Investigator assessment as measured by ECOG PS.
    progressziómentes túlélés (PFS)
    teljes túlélés (OS)
    a betegség kontroll arányát (ORR plusz stabil betegség [SD] a 4. hónapnál)
    az életminőség (ECOG státusz)
    Objektív tumor válasz (RECIST 1.1 )
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of PFS will be carried out when 110 PFS events have occurred, approximately 6 months following the completion of enrollment of 132 subjects. PSF at 4 and 6 month

    Tumor response will be monitored at baseline, every 6 weeks from Cycle 1-Day 1 through week 36, and then every 12 weeks until disease progression
    Az elsődleges PFS analízisre 110 PFS esemény bekövetkezte után kerül sor, hozzávetőlegesen 6 hónappal a 132 vizsgálati alany bevonását követően. PFS vizsgálat a negyedik és hatodik hónapban lesz esedékes.

    Követve lesz a tumor-válaszrekació a Baseline viziten, a Cycle1-Day1 vizittől 6 hetente a 36-ig hétig,majd pedig 12-hetente a beteség progressziójáig.
    E.5.2Secondary end point(s)
    1) To evaluate OS in subjects with extensive-stage SCLC who have relapsed or were refractory to no more than 1 chemotherapy regimen.
    2) To evaluate the objective ORR (RECIST 1.1 criteria, Study Reference Manual) and disease control rate (ORR + SD at 4 months) in subjects with extensive-stage SCLC who have relapsed or were refractory to 1 chemotherapy regimen as above.
    3) To evaluate PFS at 4 and 6 months.
    4) To assess investigator-reported quality of life (ECOG PS).
    5) To evaluate the treatment-related toxicities in this subject population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2),4),5),over the duration of the study
    3), 4 and 6 month
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Spain
    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
    Survival follow-ups will be conducted by telephone for all subjects every 12 weeks (+/- 14 days) from the time a subject either withdraws from treatment or at disease progression until the subject is either lost to follow-up, passes away, withdraws consent, or the Sponsor stops the study.
    Túlélés vizsgálata céljából utánkövető vizitek szükségesek 12 hetente (+/-14 nap) a vizsgálat kezelésének megszakításától vagy progrediációjától kezdődően, míg az alanyok már nem elérhetőek, elhúnytak, visszavonják beleegyezésüket vagy a Szponzor leállítja a vizsgálatot.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 132
    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
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    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 Decision2014-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-19
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