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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2022-003157-55
    Sponsor's Protocol Code Number:EF-39
    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:2023-02-03
    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 number2022-003157-55
    A.3Full title of the trial
    PANOVA-4: Pilot, Single arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
    Metasztatikus duktális hasnyálmirigy-adenokarcinóma (mPDAC) első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg
    alkalmazott tumorkezelő mezők (TTFields, 150 kHz) egykaros előzetes vizsgálata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study on the efficacy and safety of Tumor Treating Fields, atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for metastatic pancreatic carcinoma.
    A.3.2Name or abbreviated title of the trial where available
    PANOVA-4
    A.4.1Sponsor's protocol code numberEF-39
    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 SponsorNovocure GmbH
    B.1.3.4CountrySwitzerland
    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 supportNovocure GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovocure GmbH
    B.5.2Functional name of contact pointDirector, Global Clinical Operation
    B.5.3 Address:
    B.5.3.1Street AddressBusiness Village D4, Park 6
    B.5.3.2Town/ cityRoot
    B.5.3.3Post code6039
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 797556942
    B.5.6E-mailkbruckmann@novocure.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tecentriq 840 mg concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNAtezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Ductal Adenocarcinoma (mPDAC)
    Metasztatikus duktális hasnyálmirigy-adenokarcinóma (mPDAC)
    E.1.1.1Medical condition in easily understood language
    Pancreatic Cancer
    Hasnyálmirigyrák
    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 LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    Kiértékelni a RECIST v1.1 szerinti betegségkontroll-rátát (DCR) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak.
    E.2.2Secondary objectives of the trial
    To evaluate the overall survival (OS) and 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the safety and tolerability profile of TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel in patients with 1L mPDAC.
    To evaluate the progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the PFS rate at 6 months (PFS6) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    • Kiértékelni a teljes túlélést (OS) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak.
    • Kiértékelni az mPDAC-betegeken első kezelési vonalként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg alkalmazott TTFields biztonságossági és tolerálhatósági profilját.

    • Kiértékelni a RECIST v1.1 szerinti progressziómentes túlélést (PFS) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak.
    • Kiértékelni az 1 évi túlélési arányt azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak.
    • Kiértékelni a RECIST v1.1 szerinti ORR-t azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed Consent Form
    - 18 years of age and older
    - ECOG performance status of 0-1
    - Histologically or cytologically confirmed de-novo diagnosis of metastatic pancreatic ductal adenocarcinoma
    - No prior treatment for PDAC
    - Life expectancy equal to or greater than 3 months
    - Measurable disease in the abdomen, as defined by RECIST v1.1
    - Preferably, tumor accessible for tissue collection. Consent to provide blood and tumor tissue for exploratory study is highly encouraged
    - Amenable and assigned by the investigator to receive therapy with gemcitabine and nab- paclitaxel
    - Adequate hematologic and end-organ function
    - Able to operate the NovoTTF-200T device
    - A vizsgálati tervhez aláírt tájékoztatáson alapuló beleegyező nyilatkozat (betegtájékoztató és beleegyező nyilatkozat).
    - Legalább 18 éves életkor a tájékoztatáson alapuló beleegyező nyilatkozat aláírásakor.
    - ECOG szerinti teljesítőképességi státusz: 0–1.
    - Metasztatikus duktális hasnyálmirigy-adenokarcinóma szövettanilag vagy citológiailag igazolt de-novo diagnózisa.
    - Nem részesült még kezelésben a PDAC-re.
    - Legalább 3 hónap várható élettartam.
    - Mérhető betegség a hasban – a RECIST v1.1 meghatározása szerint.
    - Lehetőleg olyan daganat, amely szövetvételhez hozzáférhető. Annak vállalása, hogy felderítő vizsgálathoz vért és daganatszövetet adjon, kifejezetten szorgalmazott.
    - Alkalmas, és a vizsgáló által ki is van jelölve gemcitabinnal és nab-paclitaxellel végzendő terápiára.
    - Megfelelő hematológiai funkció és az érintett szerv megfelelő funkciója.
    - A NovoTTF-200T eszköz használatára való alkalmasság.
    E.4Principal exclusion criteria
    - Symptomatic, untreated, or actively progressing CNS metastases
    - History of leptomeningeal disease
    - Uncontrolled tumor-related pain
    - Active or history of autoimmune disease
    - Severe infection within 4 weeks prior to initiation of study treatment
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or device, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    - Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
    - Implantable electronic medical devices in the torso, such as pacemakers.
    - Tünetekkel járó, kezeletlen vagy aktívan progrediálódó központi idegrendszeri (KIR) áttétek.
    - Volt már leptomeningeális betegsége.
    - Daganattal kapcsolatos csillapítatlan fájdalom.
    - Fennálló vagy a kórtörténetben szereplő autoimmun betegség
    - Súlyos fertőzés a vizsgálati kezelés megkezdését megelőző 4 héten belül
    - Voltak már súlyos allergiás, anafilaxiás vagy egyéb túlérzékenységi reakciói kiméra vagy humanizált antitestekre vagy fúziós fehérjékre.
    - Bármilyen egyéb olyan betegség, anyagcsere-diszfunkció, fizikális vizsgálati lelet, illetve klinikai laboratóriumi lelet, amely esetén ellenjavallott vizsgálati gyógyszer vagy klinikai vizsgálatra szánt eszköz alkalmazása, illetve ami hatással lehet az eredmények értelmezésére, vagy kezelési szövődmények magas kockázatának teheti ki a beteget.
    - A gemcitabinon és a nab-paclitaxelen felül egyidejűleg kapott tumor elleni terápia.
    - A törzsbe beültetett elektronikus orvostechnikai eszköz, mint például a szívritmus-szabályozók
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with stable disease for at least 16 weeks or confirmed PR or CR.
    A RECIST v1.1 szerinti betegségkontroll-ráta (DCR) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nabpaclitaxellel egyidejűleg TTFieldset alkalmaztak – azon betegek arányaként
    mérve, akiknek a betegsége legalább 16 hétig stabil (SD) volt, vagy akiknél megerősített részleges reagálást (PR) vagy teljes reagálást (CR) tapasztaltak.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stable disease for at least 16 weeks, or confirmed PR or CR.
    A betegség legalább 16 hétig stabil (SD), vagy megerősített részleges reagálást (PR) vagy teljes reagálást (CR) tapasztaltak.
    E.5.2Secondary end point(s)
    • Overall survival (OS) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the period between the time of treatment initiation and the time of death.
    • Progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured from the time of treatment initiation.
    • 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients alive one year after treatment initiation.
    • Objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with partial or complete response between the time of treatment initiation and the time of death.
    • Progression free survival rate at 6 months (PFS6) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, defined as the proportion of patients who are alive and are progression free six months after treatment initiation.
    • Duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the time from the first occurance of a documented objective response to disease progression or death from any cause (whichever occurs first).
    • Toxicity profile in 1L mPDAC patients treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured by the rate of patients with treatment-emergent adverse events (based on CTCAE V5.0).
    • A teljes túlélés (OS) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – a kezelés megkezdésének az időpontja és a halál időpontja közötti időtartamként mérve.
    • A RECIST v1.1 szerinti progressziómentes túlélés (PFS) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – a kezelés megkezdésének az időpontjától mérve.
    • 1 évi túlélési arány azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nabpaclitaxellel egyidejűleg TTFieldset alkalmaztak – a kezelés megkezdése után egy évvel életben lévő betegek arányaként mérve.
    • A RECIST v1.1 szerinti objektív válaszarány (ORR) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – a kezelés megkezdésének az időpontja és a halál időpontja között a PRes vagy CR-es betegeknek az arányaként mérve.
    • A RECIST v1.1 szerinti progressziómentes túlélés 6 hónap elteltével (PFS6) azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – azon betegek aránya, akik a kezelés
    megkezdése után hat hónappal életben vannak és progressziómentesek.
    • A reagálás időtartama (DOR, duration of response) a RECIST v1.1 szerinti értelemben azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként atezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – a dokumentált objektív reagálás
    első előfordulásától a betegségprogresszióig vagy bármilyen okból bekövetkező halálig (ha az előbb bekövetkezik) eltelt idő.
    • Toxicitásprofil azon betegeknél, akiknél az mPDAC első vonalbeli kezeléseként
    tezolizumabbal, gemcitabinnal és nab-paclitaxellel egyidejűleg TTFieldset alkalmaztak – azon betegek arányaként mérve, akiknél a kezelés során előállt nemkívánatos események (a
    nemkívánatos események közös nevezéktanának, vagyis a CTCAE-nek a v5.0 verziója szerinti „treatment emergent adverse event”-ek) fordultak elő.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As stated in E.5.2.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Spain
    Switzerland
    Czechia
    Germany
    Hungary
    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
    LPLV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 76
    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 will be able to continue on study device and/or drugs if they are receiving study treatment at the time of study closure. Treatment continuation and follow-up will be according to local requirements.
    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 Decision2023-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 01 05:40:07 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA