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    Summary
    EudraCT Number:2016-002364-13
    Sponsor's Protocol Code Number:M16VIB
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002364-13
    A.3Full title of the trial
    MoTriColor: A phase II study of vinorelbine in advanced BRAF-like colon cancer
    Motricolor: uno studio di fase II di vinorelbina nel tumore del colon avanzato con signature “BRAF-like”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial with vinorelbine, a form of chemotherapy, in intestinal cancer with a BRAF-like signature
    Prova con vinorelbina, una forma di chemioterapia, nel cancro intestinale con una firma simile a BRAF
    A.3.2Name or abbreviated title of the trial where available
    Trial with vinorelbine, a form of chemotherapy, in intestinal cancer with a BRAF-like signature
    trial con vinorelbina, una forma di chemioterapia, nel cancro intestinale con una firma simile a BRA
    A.4.1Sponsor's protocol code numberM16VIB
    A.5.4Other Identifiers
    Name:EORTCNumber:1616
    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 SponsorTHE NETHERLANDS CANCER INSTITUTE
    B.1.3.4CountryNetherlands
    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 supportHorizon 2020
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportAntoni van Leeuwenhoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute
    B.5.2Functional name of contact pointDept of Med. Oncology
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205122446
    B.5.5Fax number31205122572
    B.5.6E-mailj.schellens@nki.nl
    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 VINORELBINA ACTAVIS - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS ITALY S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namevinorelbine
    D.3.2Product code [vinorelbine]
    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 INNVINORELBINE
    D.3.9.1CAS number 71486-22-1
    D.3.9.2Current sponsor codeVinorelbin
    D.3.9.4EV Substance CodeSUB00069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    colon carcinoma
    carcinoma del colon
    E.1.1.1Medical condition in easily understood language
    intestinal cancer
    cancro intestinale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal 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
    To determine the anti-tumor activity, as defined as doubling of progression free survival (PFS) of vinorelbine treatment in patients with BRAF-like colon cancer. This means that by vinorelbine treatment the rate of progression at 6 weeks drops to 25%.
    Determinare l’attività antitumorale, definita come raddoppiamento della sopravvivenza libera da progressione (PFS), del trattamento con vinorelbina in pazienti affetti da tumore del colon BRAF-like. Ciò significa che il tasso di progressione a 6 settimane scende al 25% mediante trattamento con vinorelbina.
    E.2.2Secondary objectives of the trial
    • To characterize the safety and tolerability of vinorelbine, as assessed by the incidence and severity of adverse events.
    • To assess efficacy of vinorelbine, as measured by overall response rate, duration of response, time to response and overall survival (OS).
    • To explore determinants (gene alteration/expression) of response to vinorelbine, as measured by baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response.
    • To explore the potential mechanism of resistance to vinorelbine, as measured by gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression.
    • Caratterizzare la sicurezza e la tollerabilità di vinorelbina, valutate in base a incidenza e gravità degli eventi avversi.
    • Valutare l’attività antitumorale di vinorelbina, misurata in base a tasso di risposta complessiva, durata della risposta, tempo alla risposta e sopravvivenza complessiva (OS).
    • Analizzare i determinanti (alterazione/espressione genica) della risposta a vinorelbina, valutati in base allo stato molecolare basale (mutazione/espressione) nel tessuto tumorale di potenziali marcatori predittivi di risposta del tumore.
    • Esplorare il potenziale meccanismo di resistenza a vinorelbina, valutato in base ai profili di alterazione/espressione genica (ovvero, al basale, alla recidiva) nel tessuto tumorale al momento della progressione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (+ TR (translational research)) must be given according to ICH/GCP and national/local regulations
    2. Written documentation of BRAF-like signature CC, including BRAFm and BRAFwt, as determined by the validated assay of Agendia
    3. Age = 18 years
    4. Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon not in a previously irradiated area, treated with one or two lines of standard of care therapy, including BRAF inhibitors, for locally advanced disease and metastatic disease
    5. WHO performance status of 0-1
    6. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
    7. Negative urine pregnancy test for female patients with childbearing potential
    1. Consenso informato scritto (+ TR [ricerca traslazionale]) in conformità alle norme di Buona pratica clinica della Conferenza internazionale sull’armonizzazione (ICH/GCP) e alla normativa nazionale/locale
    2. Documentazione scritta di CC con profilo BRAF-like, tra cui BRAFm e BRAFwt, determinato mediante test validato di Agendia
    3. Età >18 anni
    4. Adenocarcinoma metastatico del colon istologicamente dimostrato e misurabile (Criteri di valutazione della risposta nei tumori solidi [RECIST] v.1.1), con sede in un’area non precedentemente irradiata, trattato con una o due linee di terapia standard, inclusi gli inibitori di BRAF, per malattia localmente avanzata e malattia metastatica
    5. Stato di validità OMS di 0-1
    6. Soggetto in grado di, e disponibile a sottoporsi a prelievi di sangue per l’analisi farmacodinamica (PD)
    7. Soggetto in grado di, e disponibile a sottoporsi a biopsia tumorale prima dell’avvio, durante e alla fine del trattamento
    8.Aspettativa di vita >3 mesi, che consenta un follow-up adeguato della valutazione della tossicità e dell’attività antitumorale
    9. Valori minimi accettabili degli esami di laboratorio per la sicurezza:
    a. Conta assoluta dei neutrofili (ANC) >1,5 x 109/l
    b. Conta piastrinica >100 x 109/l
    c. Emoglobina >6,0 mM/l
    d. Funzione epatica definita da livelli sierici di bilirubina <1,5 x il limite superiore della norma (ULN), ALAT e ASAT <2,5 x ULN o ALAT e ASAT <5 x ULN nei pazienti con metastasi epatiche
    e. Funzione renale definita da livelli sierici di creatinina <1,5 x ULN
    f. Clearance della creatinina >50 ml/min (secondo la formula di Cockroft-Gault)
    10. Test di gravidanza urinario negativo per le pazienti in età fertile
    E.4Principal exclusion criteria
    1. Any treatment with investigational drugs, including BRAF inhibitors, within 28 days prior to receiving the first dose of investigational treatment
    2. Symptomatic or untreated leptomeningeal disease
    3. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy (for at least 4 weeks) are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids
    4. Impairment of gastrointestinal (GI) function or GI disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, any condition inducing malabsorption, small bowel resection)
    5. Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection
    6. Known allergy or any other adverse reaction to any of the drugs or to any related compound
    7. Women who are pregnant or breast feeding
    8. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
    9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery
    10. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
    11. Patients with a known history of hepatitis B or C
    12. Known hypersensitivity to study drug or excipients
    1.Qualsiasi trattamento con farmaci sperimentali, inclusi gli inibitori di BRAF, nei 28 giorni precedenti la somministrazione della prima dose di trattamento sperimentale
    2. Malattia leptomeningea sintomatica o non trattata
    3.Metastasi cerebrali sintomatiche. È consentito l’arruolamento di pazienti, trattati o meno in precedenza per queste condizioni, che appaiano asintomatici in assenza di terapia corticosteroidea e anticonvulsivante (per almeno 4 settimane). La radioterapia per metastasi cerebrali deve essere stata completata almeno 6 settimane prima dell’avvio del trattamento dello studio. Le metastasi cerebrali devono essere stabili, con verifica mediante esami di imaging (ad es., RM o TC cerebrale eseguita allo screening che non dimostri alcuna attuale evidenza di metastasi cerebrali in progressione). I pazienti non possono ricevere farmaci antiepilettici induttori enzimatici o corticosteroidi
    4. Compromissione della funzione gastrointestinale (GI) o patologia GI (ad es., patologie ulcerative, nausea non controllata, vomito, diarrea, qualsiasi condizione che induca malassorbimento, resezione dell’intestino tenue)
    5. Altra malattia concomitante non controllata, tra cui grave infezione intercorrente non controllata
    6. Allergia nota o qualsiasi altra reazione avversa a uno qualsiasi dei farmaci o a qualsiasi composto correlato
    7. Donne in gravidanza o che allattano al seno
    8.Metodi contraccettivi non affidabili. Sia gli uomini che le donne arruolati in questa sperimentazione devono acconsentire a utilizzare un metodo contraccettivo affidabile per tutta la durata dello studio (sono metodi contraccettivi adeguati il preservativo, la sterilizzazione, altre misure contraccettive di barriera preferibilmente in combinazione con preservativi)
    9. Radioterapia, immunoterapia o chemioterapia nelle ultime 4 settimane prima della somministrazione della prima dose di trattamento sperimentale. È consentita la radioterapia palliativa (1 x 8 Gy)
    10.Pazienti sottoposti a qualsiasi intervento chirurgico maggiore nelle ultime 2 settimane prima dell’avvio del farmaco dello studio o che non si siano ripresi completamente da un precedente intervento chirurgico
    11. Pazienti con patologia infettiva non controllata o infezione nota da virus dell’immunodeficienza umana di tipo 1 (HIV-1) o 2 (HIV-2)
    12. Pazienti con anamnesi nota di epatite B o C
    13. Pazienti con comorbilità cardiache (infarto miocardico nei 6 mesi precedenti l’inizio dello studio, insufficienza cardiaca congestizia di classe =III in base alla classificazione della New York Heart Association [NYHA] [Associazione dei cardiologi di New York] o angina pectoris instabile), ipertensione non controllata (pressione arteriosa sistolica >150 mm Hg e/o pressione diastolica >90 mm Hg) o intervallo QT prolungato (>440 ms per gli uomini, >460 ms per le donne)
    14. Altra condizione medica o psichiatrica o anomalia di laboratorio grave, acuta o cronica, che possa aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco dello studio o che possa interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renderebbe il paziente un candidato non idoneo per lo studio
    15. Ipersensibilità nota al farmaco dello studio o agli eccipienti
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the safety and anti-tumor activity of vinorelbine in paitents with BRAF-like colon cancer, who are previously treated with maximally two lines of standard of care therapy for advanced disease. The study will be powered to demonstrate a doubling of progression free survival (PFS) of vinorelbine treatment compared with historic controls. This means that by vinorelbine treatment the rate of progression at 6 weeks drops to 25%
    L’endpoint primario è il raddoppiamento della PFS rispetto ai controlli storici.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    alla fine del processo
    E.5.2Secondary end point(s)
    • To characterize the safety and tolerability of vinorelbine, as assessed by the incidence and severity of adverse events.
    • To assess efficacy of vinorelbine, as measured by overall response rate, duration of response, time to response and overall survival (OS).
    • To explore determinants (gene alteration/expression) of response to vinorelbine, as measured by baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response.
    • To explore the potential mechanism of resistance to vinorelbine, as measured by gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression.
    Caratterizzare la sicurezza e la tollerabilità di vinorelbina, valutate in base a incidenza e gravità degli eventi avversi.
    • Valutare l’attività antitumorale di vinorelbina, misurata in base a tasso di risposta complessiva, durata della risposta, tempo alla risposta e sopravvivenza complessiva (OS).
    • Analizzare i determinanti (alterazione/espressione genica) della risposta a vinorelbina, valutati in base allo stato molecolare basale (mutazione/espressione) nel tessuto tumorale di potenziali marcatori predittivi di risposta del tumore.
    • Esplorare il potenziale meccanismo di resistenza a vinorelbina, valutato in base ai profili di alterazione/espressione genica (ovvero, al basale, alla recidiva) nel tessuto tumorale al momento della progressione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial
    alla fine del processo
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 EEA7
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months4
    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 months6
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-12-15. Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Motricolor
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-03-17
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