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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-000349-59
    Sponsor's Protocol Code Number:0244190615-02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000349-59
    A.3Full title of the trial
    METAL (METformin in Advanced Lung cancer) study: PHASE II STUDY OF METFORMIN PLUS ERLOTINIB IN SECOND LINE THERAPY OF STAGE IV NON SMALL CELL LUNG CANCER (NSCLC) PATIENTS
    Studio METAL (metformina nel tumore del polmone in fase avanzata): studio di fase II di metformina più erlotinib in seconda lionea di trattamento in pazienti con non small cell lung cancer metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    METAL trial: metformin plus erlotinib in patients with metastatic lung cancer in second line therapy
    Metal trial: combinazione di metformina più erltoinib in seconda linea di trattamento in pazienti con tumore del polmone avanzato
    A.4.1Sponsor's protocol code number0244190615-02
    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 Sponsordepartment of experimental and clinical medicine "F. Magrassi"
    B.1.3.4CountryItaly
    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 supportdepartment of experimental and clinical medicine "F. Magrassi"
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationdepartment of experimental and clinical medicine "F. Magrassi"
    B.5.2Functional name of contact pointfortunato ciardiello
    B.5.3 Address:
    B.5.3.1Street Addressvia pansini 5
    B.5.3.2Town/ citynapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number00390815666745
    B.5.5Fax number00390815666732
    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 tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderroche registration limited 6 flacon way shire park welwyn garden city AL7 1tw regno unito
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameerlotinib
    D.3.2Product code L01XE03
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB
    D.3.9.1CAS number 183321-74-6
    D.3.9.4EV Substance CodeSUB16423MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Patients with metastatic non small cell lung cancer in second line therapy
    pazienti con NSCLC in fase metastatica in seconda line adi trattamento
    E.1.1.1Medical condition in easily understood language
    Patinets with advanced lung cancer
    pazienti con tumore del polmone in stadio avanzato
    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 study is a two-part trial, where a safety Run-in part of metformin combined with erlotinib will be followed by a Phase II part of metformin plus erlotinib. Primary objective of the safety run in part is to determine the MTD and the recommended Phase II dose of metformin combined with erlotinib as second-line treatmentin subjects with NSCLC harboringwild-type EGFR gene.
    Primaryobjective of the phase II part are:
    • To assess the percentage of patientswithoutdiseaseprogressionat 10 weeks.
    • To assess the median progression free survival of the second-line combination metformin and erlotinib in subjects with NSCLCharboring wild-type EGFR gene.

    Lo studio è diviso in due parti: UNA SAFETY RUN IN PART E UNA PHASE II PART.
    l'obiettivo primario della safety run in part è quello di definire la dose massima tollerata (MTD) e la dose di metformina+erlotinib da testare nello studio di fase II in pazienti con NSCLC in II linea di trattamento, che non presentano mutazioni nel gene EGFR.
    Gli obiettivi primari della phase II part sono:
    - Definire la percentuale di pazienti liberi da progressione a 10 settimane
    - Definire la sopravvivenza mediana libera da progressione in II linea in pazienti con NSCLC che non presentano mutazione del gene EGFR
    E.2.2Secondary objectives of the trial
    Secondary objectives of the safety run in part are:
    • To assess the pharmacokinetics (PK) of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore antitumor activity of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore candidate markers or tumor characteristics predictive of antitumor activity
    Secondary objectives of the phase II part are:
    • To assess the anti-tumor activity, in terms of response rate, overall survival, QoL, of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore candidate markers or tumor characteristics predictive of antitumor activity

    gli obiettivi secondari della safety run in part sono:
    - Valutare la farmacocinetica dell’associazione metformina ed erlotinib
    - Determinare la sicurezza e la tollerabilità dell’associazione metformina ed erlotinib Valutare l’attività antitumorale della combinazione metformina ed erlotinib
    - Valutare marcatori o caratteristiche tumorali predittive dell’attività antitumorale;
    - Esplorare marcatori circolanti presenti nel siero.
    Gli obiettivi secondari della Phase II part sono:
    - Definire l’attività antitumorale in termini di percentuale di risposta, sopravvivenza globale e qualità di vita dell’associazione metformina ed erlotinib
    - Determinare la sicurezza e la tollerabilità dell’associazione metformina ed erlotinib
    - Valutare marcatori o caratteristiche tumorali predittive dell’attività antitumorale;

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consents
    • Patients be age >18 years
    • Patients must have histologically or cytologically confirmed non small cell carcinoma of the lung and are previously treated
    • Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system).
    • Patients must have a Life Expectancy of greater than 12 weeks.
    • Patients must have an ECOG performance status 0 or 1 (Karnofsky> 70%).
    • Patients must have normal organ and marrow function as defined below, within one week prior to randomization:
    - Neutrophils> 1.5 x 109/L, platelets > 100 x 109/L, and hemoglobin >9 g/dL
    - Bilirubin level either normalor <1.5 x ULN
    - ASAT and ALAT <2.5 x ULN (< 5 x ULN if liver metastasis are present)
    - Serum creatinine < 1.5 x ULN
    - Alkaline phosphatase < 4 x ULN

    • O2 saturation >93%.
    • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    • Patients must have the ability to understand and the willingness to sign a written informed consent document.
    1. Modulo di consenso informato approvato dal Comitato Etico firmato e datato
    2. Età maggiore o uguale a18
    3. Diagnosi istologica o citologica di carcinoma polmonare non a piccole cellule (NSCLC) precedentemente trattato
    4. Malattia misurabile in IV stadio (compresi gli stadi M1a, M1b o malattia ricorrente, secondo la 7° edizione della classificazione TNM)
    5. Aspettativa di vita superiore alle 12 settimane
    6. Performance status 0-1, secondo la scala ECOG (Karnofsky> 70).
    7. Buona funzionalità d’organo e del midollo entro una settimana prima della randomizzazione definita come di seguito:
    -Conta assoluta dei neutrofili (ANC) > 1,500 cellule/mm3, piastrine >100x109/L ed emoglobina >9 g/dL
    - Bilirubina < 1.5 x ULN (Limite Superiore di Normalità)
    - ASAT (SGOT), ALAT (SGPT) < 2.5 x ULN (in caso di metastasi epatiche sono accettati valori < 5 ULN)
    - Creatinina serica < 1.5 x ULN
    - Fosfatasi alcalina < 4 x ULN
    - Saturazione dell’ossigeno >93%
    8. Accettazione da parte di donne in età fertile e degli uomini con potenziale riproduttivo all’utilizzo di metodi contraccettivi adeguati ed efficaci (metodo ormonale o barriera di controllo delle nascite; astinenza) prima dell’entrata in studio, dalla firma del consenso informato e per tutta la durata dello studio. In caso di gravidanza odi sospetto di gravidanza durante la partecipazione a questo studio, la paziente deve informare immediatamente il Suo medico curante.
    9. I pazienti devono avere la capacità di comprendere la volontà di firmare un documento di consenso informato scritto.
    E.4Principal exclusion criteria
    • Patients with EGFR/ALK mutated histologically proven NSCLC
    • Type 1 or 2 Diabetes
    • Patients with uncontrolled undercurrents illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
    • Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.
    • Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or other agents used in the study are excluded.
    • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
    • Any investigational agent(s) within 4 weeks prior to entry
    • Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
    • Legal incapacity or limited legal capacity
    • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
    • Women who are pregnant or breastfeeding
    • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for  5 years will be allowed to enter the trial)
    La presenza di una qualsiasi delle caratteristiche sotto elencate non consentirà al paziente di prendere parte allo studio:
    1. Pazienti affetti da NSCLC con mutazione del gene EGFR o riarrangiamento di ALK
    2. Diabete mellito di tipo I o II
    3. Pazienti con infezioni, insufficienza cardiaca congestizia, angina instabile (sintomatologia di angina a riposo), nuova manifestazione di angina (con inizio negli ultimi 3 mesi), infarto miocardico nei 6 mesi precedenti l’inizio del trattamento, aritmia cardiaca, malattia psichiatrica o sociali che potrebbero interferire con la partecipazione del paziente allo studio o con la valutazione dei risultati dello studio.
    4. Pazienti trattati con immunoterapia, terapia ormonale e/o radioterapia entro 2 settimane prima di entrare nello studio. Nota: Coloro che non hanno recuperato da eventi avversi dovuti a questi farmaci somministrati saranno considerati non ammissibili.
    5. Pazienti con metastasi cerebrali non controllate. Nota: I pazienti con metastasi cerebrali devono avere lo stato neurologico stabile dopo terapia locale (chirurgia o radioterapia) per almeno 2 settimane, in assenza di disfunzione neurologica
    6. Ipersensibilità conosciuta al farmaco in studio, alla classe di farmaci cui appartiene il farmaco in studio o agli eccipienti presenti nella formulazione.
    7. Concomitante terapia sistemica immunitaria cronica, chemioterapia o terapia ormonale non indicate nel protocollo di studio.
    8. Qualsiasi farmaco sperimentale entro 4 settimane prima dell'arruolamento nello studio.
    9. Precedente esposizione a EGF, anticorpi monoclonali, inibitori della trasduzione del segnale o terapia con farmaci anti- EGFR.
    10. Incapacità giuridica o capacità legale limitata
    11. Condizione medica o psicologica che, a parere dello sperimentatore non permetterebbe al paziente di completare lo studio o firmare il consenso informato significativo.
    12. Donne in gravidanza o in allattamento. Donne potenzialmente fertili devono fare un test di gravidanza entro i 7 giorni precedenti l’inizio del trattamento, e comunque prima dell’inizio del trattamento deve essere documentato il risultato di un test di gravidanza negativo.
    13. Precedente o concomitante tumore maligno, che si distingue per sito primario d’insorgenza o istologia dal carcinoma del polmone non a piccole cellule nei 5 anni precedenti l’inclusione, ad eccezione del carcinoma della pelle purchè non-melanoma edel carcinoma in situ della cervice uterina.
    E.5 End points
    E.5.1Primary end point(s)
    The study is a two-part trial, where a safety Run-in part of metformin combined with erlotinib will be followed by a Phase II part of metformin plus erlotinib. Primary objective of the safety run in part is to determine the MTD and the recommended Phase II dose of metformin combined with erlotinib as second-line treatmentin subjects with NSCLC harboringwild-type EGFR gene.
    Primaryobjective of the phase II part are:
    • To assess the percentage of patientswithoutdiseaseprogressionat 10 weeks.
    • To assess the median progression free survival of the second-line combination metformin and erlotinib in subjects with NSCLCharboring wild-type EGFR gene.

    o studio è diviso in due parti: UNA SAFETY RUN IN PART E UNA PHASE II PART.
    l'obiettivo primario della safety run in part è quello di definire la dose massima tollerata (MTD) e la dose di metformina+erlotinib da testare nello studio di fase II in pazienti con NSCLC in II linea di trattamento, che non presentano mutazioni nel gene EGFR.
    Gli obiettivi primari della phase II part sono:
    - Definire la percentuale di pazienti liberi da progressione a 10 settimane
    - Definire la sopravvivenza mediana libera da progressione in II linea in pazienti con NSCLC che non presentano mutazione del gene EGFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 mounths
    18 mesi
    E.5.2Secondary end point(s)
    Secondary objectives of the safety run in part are:
    • To assess the pharmacokinetics (PK) of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore antitumor activity of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore candidate markers or tumor characteristics predictive of antitumor activity
    Secondary objectives of the phase II part are:
    • To assess the anti-tumor activity, in terms of response rate, overall survival, QoL, of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene.
    • To explore candidate markers or tumor characteristics predictive of antitumor activity

    gli obiettivi secondari della safety run in part sono:
    - Valutare la farmacocinetica dell’associazione metformina ed erlotinib
    - Determinare la sicurezza e la tollerabilità dell’associazione metformina ed erlotinib Valutare l’attività antitumorale della combinazione metformina ed erlotinib
    - Valutare marcatori o caratteristiche tumorali predittive dell’attività antitumorale;
    - Esplorare marcatori circolanti presenti nel siero.
    Gli obiettivi secondari della Phase II part sono:
    - Definire l’attività antitumorale in termini di percentuale di risposta, sopravvivenza globale e qualità di vita dell’associazione metformina ed erlotinib
    - Determinare la sicurezza e la tollerabilità dell’associazione metformina ed erlotinib
    - Valutare marcatori o caratteristiche tumorali predittive dell’attività antitumorale;

    E.5.2.1Timepoint(s) of evaluation of this end point
    18 mounths
    18 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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
    Until PFS or wishes of the patient or investigator decision
    Fino a progressione di malattia o ritiro del consenos o volontà del paziente
    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
    E.8.9.2In all countries concerned by the trial months18
    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: 60
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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
    nessuno
    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 department of experimental and clinical medicine F magrassi
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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