Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35474   clinical trials with a EudraCT protocol, of which   5826   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003324-36
    Sponsor's Protocol Code Number:NT14035-3/2013
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-11
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2013-003324-36
    A.3Full title of the trial
    Kinetically guided removal of plazma pegylated liposomal doxorubicin to enhance the benefit of cytostatic therapy of patients with ovarian cancer.
    Kineticky řízené odstranění plazmatického pegylovaného liposomálního doxorubicinu ke zvýšení benefitu cytostatické léčby karcinomu ovarií.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The removal of plazma pegylated liposomal doxorubicin for the benefit of cytostatic therapy of patients with ovarian cancer.
    Odstranění plazmatického pegylovaného liposomálního doxorubicinu ke zvýšení benefitu cytostatické léčby karcinomu ovarií.
    A.3.2Name or abbreviated title of the trial where available
    The removal of plazma pegylated liposomal doxorubicin for the benefit of therapy.
    Odstranění plazmatického pegylovaného liposomálního doxorubicinu ke zvýšení benefitu léčby.
    A.4.1Sponsor's protocol code numberNT14035-3/2013
    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 SponsorCharles University in Prague, Faculty of Medicine in Hradec Králové
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCharles University in Prague, Faculty of Medicine in Hradec Králové
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Oncology and Radiotherapy, Charles University in Prague, University Hospital in Hradec Králové
    B.5.2Functional name of contact pointStanislav Filip
    B.5.3 Address:
    B.5.3.1Street AddressSokolská 548
    B.5.3.2Town/ cityHradec Králové
    B.5.3.3Post code50005
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420495834618
    B.5.6E-mailfilip@fnhk.cz
    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 Caelyx
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameCAELYX CARTON 20 mg/10 ml
    D.3.2Product code EU/1/96/011/001
    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.3.11 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
    Primary aim: enhanced therapeutic benefit of liposomal doxorubicin - a drug indicated for ovarian cancer resistant to chemotherapy with the first line drugs. This approach can be considered a model study for another formulation of liposomal drugs useful for cancer chemotherapy.
    Primární cíl: Zvýšení terapeutického benefitu liposomálního doxorubicinu – cytostatika indikovaného pro ovariální karcinom rezistentní na léčbu cytostatiky první volby. Tato studie může sloužit jako modelová k výzkumu zvýšeného benefitu u dalších liposomálních cytostatik.
    E.1.1.1Medical condition in easily understood language
    The aim is enhanced therapeutic benefit of liposomal doxorubicin - a drug indicated for ovarian cancer resistant to chemotherapy with the first line drugs.
    Cílem je zýšení terapeutického benefitu liposomálního doxorubicinu – cytostatika indikovaného pro ovariální karcinom rezistentní na léčbu cytostatiky první volby.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective to be solved in this project is the issue of circulation of nanotechnologically modified anticancer drugs in the time when they have no effect and may be the source of adverse side-effects and thus influence significantly both the treatment efficacy and „benefit cost“. After Cmax is achieved in the tumour tissue further circulation of liposomal cytostatic drug is not effective. Plasma level leads only to the development of adverse efects but with no effect. With a suitable extracorporeal elimination system it is possible markedly limit acute toxic effects of chemotherapy. For the therapy with rheohemapheresis we suggest to use pegylated liposomal doxorubicine in female patients with ovarian cancer. Newly, we wish to monitore still unexplored changes of hematologic, immunologic and metabolic parameters. The proposed project is in consistence with the program of the Ministry of Health, Czech Republic - 03. Oncology.
    Předmětem řešení projektu je problém cirkulace nanotechnologicky upravených protinádorových léků v období, kdy již nejsou účinná a mohou být zdrojem vedlejších nežádoucích projevů, které významně ovlivňují jak efektivitu léčby, tak „benefit cost“. Po dosažení Cmax v nádorové tkáni je další cirkulace liposomálního cytostatika neúčinná. Plazmatická hladina vede jen k vzniku nežádoucích vedlejších efektů (zejména zažívacího traktu a kůže), ale nemá léčebný efekt. Vhodným extrakorporálním eliminačním systémem je možno výrazně omezit akutní toxické účinky chemoterapie. Takovou léčbu pomocí rheohemaferézy (kaskádové filtrace, která je považována za nejvhodnější eliminační systém pro tuto potřebu) navrhujeme při léčbě pacientek s karcinomem ovarií pegylovaným liposomálním doxorubicinem.
    E.2.2Secondary objectives of the trial
    Secondary aim: identification of pathologic factors (covariates), that might significantly modify the liposomal doxorubicin kinetics and therapeutic effectiveness of such chemotherapy (age, progression of tumours with hepatic metastases,and others).
    The project is compatible with principles and priorities of Resort program RPV III. chapter 7. 03, confined to oncology.
    Priority: “Combination of molecular-directed therapy with  classical approach (chemotherapy)“ and Contributions: “Improved medical care of patients suffering from cancers“.
    Sekundární cíl: vytipovat faktory (kovariáty), které se významně promítají do kinetiky i účinnosti chemoterapie liposomálním doxorubicinem.
    Svým obsahem projekt naplňuje základní cíle a priority Resortního programu RPV III. kapitola 7. 03, věnované onkologii.
    Priority: „Kombinace molekulárně-cílené léčby s klasickými postupy (chemoterapií)“ a Přínosy: „Zlepšení výsledku péče o nemocné s nádory“.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteria for inclusion: 1 / Histologically confirmed epithelial ovarian cancer, fallopian tube or peritoneal carcinoma, 2 / Previous chemotherapy containing platinum and paclitaxel with the rise of resistance to chemotherapy; 3/Progression of disease (clinical findings, imaging techniques - CT, PET-CT MR elevation of tumor marker CA125) 4 / Age 18 years 5 / Performance status ≤ 1, 6 / Life expectancy 12 weeks, 7 / Adequate hematopoietic, hepatic and renal function; 8 / Signed informed consent.
    Kriteria k přijetí do studie a kritéria vylučující:
    Kritéria pro zařazení: 1/ Histologicky potvrzený epiteliální karcinom ovaria, vejcovodu nebo peritoneální karcinom; 2/ Předchozí chemoterapie obsahující platinu a paklitaxel s nárustem rezistence na podávanou chemoterapii; 3/Potvrzená progrese onemocnění (klinický nález, zobrazovací metódy - CT, PET- CT, MR; elevace nádorového markeru CA125); 4/ Věk 18 let; 5/ Performance status ≤ 1; 6/ Life expectancy 12 týdnů; 7/ Adekvátní hematopoetické, jaterní a ledvinné funkce; 8/ Podepsaný informovaný souhlas.
    E.4Principal exclusion criteria
    Criteria for exclusion: 1 / Pregnancy and lactation, 2 / Allergy to doxorubicin and other anthracyclines, 3 / Severe cardiac disease (arrhythmia, cardiac insufficiency, status post myocardial infarction), 4 / Prior treatment with anthracyclines up to the maximum cumulative dose (550mg / m2), 5 / significant persistent myelosuppression induced by previous treatment with cytotoxic agents, 6 / Generalized infection 7 / Severe impairment of liver function.
    Kritéria pro vyřazení: 1/ Gravidita a kojení; 2/ Alergie na doxorubicin a jiné antracykliny; 3/ Závažné srdeční onemocnění (arytmie, kardiální insuficience, stav po infarktu myokardu); 4/ Předchozí léčba antracykliny až do jejich maximální kumulativní dávky (550mg/m2); 5/ Výrazná přetrvávající myelosuprese vyvolaná předchozí léčbou cytotoxickými látkami; 6/ Generalizovaná infekce; 7/ Závažná porucha jaterních funkcí.
    E.5 End points
    E.5.1Primary end point(s)
    Estimation of individual doxorubicin kinetics (cycle 1): to determine doxorubicin plasma concentration after the first doxorubicin i.v. dose, 2 ml will be taken from a venous blood. In respect to both the clearance of doxorubicin and RHP, the first postinfusion sample will be drawn at 30 min after the termination of the first infusion. Additional samples will be taken at 44, 46, 72 a 150 postinfusion hours. Doxorubicin plasma concentration will be used for estimation of individual kinetic parameters: the systemic clearance, and AUC (area under the curve of doxorubicin plasma concentration in time after the start of infusion ). These data will be compared with those obtained in the literature. A slow rate of doxorubicin clearance and high exposure to the drug estimated after the first infusion would indicate the need of a higher rate of RHP or its prolongation after dose 2-4 within cycle 2-4 in order to achieve equipotent scheduled removal of the liposomal doxorubicin administered dose. Evaluation of data obtained from 40 cycles and correlation of individual doxorubicin kinetic parameters with both RHP effectiveness, and tolerability related to chemotherapy with liposomal doxorubicin is expected to generate instructions how to guide kinetically apheretic procedures.
    Odhad individuální kinetiky doxorubicinu (cyklus 1): Před první dávkou cytostatika a po jejím dokončení odebrat 2 ml krve v následujících intervalech: 30 min, 44, 46, 72 a 150 hod po skončení infúze. Odběry realizovat z jiné žíly, než té, která sloužila k podávání léčiva. Z plazmatických koncentrací budou vypočteny individuální kinetické parametry doxorubicinu: plazmatická clearance a AUC (plocha pod køivkou) a porovnány s literárními údaji. Pomalá rychlost clearance a vysoká exposice doxorubicinu (AUC) zjištěná v cyklu 1, bude vyžadovat rychlejší ev. prodlouženou RHF v cyklu 2-4 tak, aby byla odstraněna doporučená frakce z podané dávky (přibližně 60%) v ekvipotentní podobě. Vyhodnocení 40 cyklů a korelace výsledků individuální kinetiky s účinností RHF a také s indikátory účinnosti a tolerability chemoterapie liposomálním doxorubicinem vyústí v doporučení, jak RHF kineticky řídit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the years 2013 - 2014: patients will be planned to be enrolled in respect to eligibility criteria, cyclus 1-4 and 2015: the termination of data collection and final evaluation including that based on statistical methodology
    V roce 2013 - 2014: zařazení pacientů indikovaných k chemoterapii, cyklus 1-4, sběr dat a průběžné hodnocení výsledků, prezentace výsledků na tuzemských i zahraničních kongresech, v recenzovaných domácích odborných časopisech. 2015:
    E.5.2Secondary end point(s)
    Clinical and pathological response to therapy. Patients will be followed during therapy and for 1 year after the completion of therapy (follow-up period) using physical examination, ultrasonography, RTG, computed tomographic (CT) scanning CT and /or MR), tumor biomarker titration (CA 125) and residual illness evaluation graded according to WHO classification - remission (no sign of tumor progression), partial remission (50% decrease in tumour size), tumour persistence (no change). TNM classification will be used as well (Sobin and Witekind, 1997).
    Klinická a patologická odpověď na léčbu - účinnost (follow-up) po dobu 1 roku. Metody monitorování: zobrazovacími metodami (UZ, Rtg, CT ev. MRI), vyšetřením tu markerů CA 125, hodnocením reziduální nemoci podle stupnice WHO - remise (o 100%), parciální remise (zmenšení tumoru o 50%), perzistence (beze změny). TNM klasifikace bude rovněž využita (Sobin a Witekind, 1997).
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the years 2013 - 2014: patients will be planned to be enrolled in respect to eligibility criteria, cyclus 1-4 and 2015: the termination of data collection and final evaluation including that based on statistical methodology. The outcome will be presented and published as a paper in an international medical journal.
    V roce 2013 - 2014: zařazení pacientů indikovaných k chemoterapii, cyklus 1-4, sběr dat a průběžné hodnocení výsledků, prezentace výsledků na tuzemských i zahraničních kongresech, v recenzovaných domácích odborných časopisech. 2015: dokončení sběru dat a jejich finální statistické zpracování, publikace výsledků v mezinárodních odborných impaktovaných časopisech.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state10
    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)
    Dispensarization of patients after treatment.
    Dispenzarizace nemocných po léčbě.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-30
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA