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    Summary
    EudraCT Number:2015-004472-30
    Sponsor's Protocol Code Number:MITO23
    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:2017-12-21
    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 number2015-004472-30
    A.3Full title of the trial
    Randomized phase III trial on Trabectedin (ET-743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    Studio di Fase III con Trabectedina versus la migliore chemioterapia a scelta del curante nelle pazienti con recidiva di tumore ovarico, delle tube di Falloppio o primitivo del peritoneo che presentino una mutazione del BRCA o il fenotipo BRCAness
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    overall survival of patients with recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype treated with trabectedin compared to a standard treatment
    valutare la sopravvivenza globale di pazienti con recidiva di tumore ovarico, delle tube di Falloppio o primitivo del peritoneo con mutazione del BRCA o con fenotipo BRCAness, trattati con trabectedina rispetto ad un trattamento standard
    A.3.2Name or abbreviated title of the trial where available
    MITO 23
    MITO 23
    A.4.1Sponsor's protocol code numberMITO23
    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 SponsorFONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    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 supportPharma Mar S.A.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportFondazione IRCCS Istituto Nazionale Tumori
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale Tumori
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Giacomo Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02.23903818-3063
    B.5.5Fax number02.23903991
    B.5.6E-mailtrialcenter@istitutotumori.mi.it
    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 YONDELIS - 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR S.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 nameYondelis
    D.3.2Product code ET-743
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNTrabectedina
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeCT 7917
    D.3.9.4EV Substance CodeEU/1/07/417/001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 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
    recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    pazienti con recidiva di tumore ovarico, delle tube di Falloppio o primitivo del peritoneo che presentino una mutazione del BRCA o il fenotipo BRCAness
    E.1.1.1Medical condition in easily understood language
    patients with recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype
    pazienti con recidiva di tumore ovarico, delle tube di Falloppio o primitivo del peritoneo che risultano BRCA mutate o hanno il fenotipo BRCAness
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006888
    E.1.2Term Ca ovary
    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
    The primary objective is to compare the treatment groups in terms of overall survival (OS)
    L’obiettivo primario è quello di comparare i gruppi di trattamento in termini di overall survival (OS)
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the treatment groups in terms of:
    • Progression free survival (PFS) In case of CA 125 progression according to GCIG criteria is documented, a confirmatory CT scan and a radiological CT progression will be required.
    • Radiological response rate (in patients with measurable disease)
    • Duration of response
    • CA-125 response rate per GCIG and change in CA-125
    • Toxicity profile
    • Quality of Life assessments using QLQ-C30 and QLQ-OV28
    questionnaires.
    Gli obiettivi secondari sono quelli di comparare i gruppi di trattamento in termini di:
    • Intervallo libero da progressione (PFS). In caso di documentata progressione di CA125 secondo criteri GCIG, è richiesta una conferma radiologica di progressione;
    • Risposta radiologica (in pazienti con malattia misurabile);
    • Durata della risposta;
    • Risposta sierologica del marcatore CA-125 secondo i criteri GCIG;
    • Tossicità;
    • Qualità di vita mediante la compilazione di questionari QLQ-C30 e QLQ-OV28.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.5-Thu Oct 15 00:00:00 CEST 2015-Translational Sub Studies-The translational end points are aimed at evaluating the impact of altered gene and microRNA (miRNA) expression on trabectedin efficacy. This analysis will allow considering which genes are involved in the so called BRCAness phenotype thought to be more sensitive to this treatment, and how these genes are regulated.
    1.5-Thu Oct 15 00:00:00 CEST 2015-Sottostudio traslazionale al protocollo -Gli obiettivi dello studio traslazionale hanno lo scopo di valutare l’impatto dell’espressione dei geni alterati e dei microRNA (miRNA)sull’efficacia della Trabectedina. Questa analisi consentirà di valutare quali geni sono coinvolti nel cosidetto fenotipo BRCAness che si ritiene essere patognomonico alla sensibilità al trattamento con Trabectedina e come questi geni sono regolati
    E.3Principal inclusion criteria
    1. Female of age 18 years or older
    2. Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
    3. Platinum resistant or sensitive patients with either:
    a. BRCA mutated patients
    b. BRCAness phenotype: patients who have received and responded (subsequent PFI>6 months) to at least 2 previous platinum based chemotherapy lines
    c. Platinum sensitive patients who are not able to receive or not willing to receive other platinum treatments
    4. Measurable and evaluable disease per RECIST 1.1(Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
    5. ECOG performance status 0 or 1
    6. No limits in the number of previous chemotherapy lines, previous treatment with parp inhibitors is allowed
    7. Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit normal
    8. Life expectancy of at least 3 months
    9. Adequate organ functions:
    a. Hematopoietic; Absolute neutrophil count ≥ 1,500/mm3
    b. Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dl
    c. Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)* ; Alkaline Phosphatase ≤ 2.5 times ULN*; Bilirubin≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present
    d. Renal; Creatinine Clearance ≥ 45 ml/min or Serum Creatinine ≤1.5 x ULN
    e. Serum Albumin >2.5 g/dl
    10. No other invasive malignancy within the past 3 years except non-melanoma skin cancer or in situ cervical cancer (patients with previous cancers may be enrolled providing that no recurrences have be reported in the last 3 years)
    11. Written Informed Consent
    12. Adequately recovered from the acute toxicity of any prior treatment
    13. For agents in the standard arm, also refer to the local prescribing information with regards to warnings, precautions, and contraindications
    1. Pazienti con età ≥ 18 anni
    2. Tumore epiteliale ovarico, tumore alle tube di fallopio o tumore peritoneale primario in stadio avanzato o metastatico istologicamente o citologicamente documentato;
    3. Pazienti platino resistenti o platino sensibili con:
    a. Mutazione BRCA nota
    b. Pazienti con fenotipo BRCAness: le pazienti devono aver ricevuto e risposto almeno a 2 precedenti linee di chemioterapia a base di platino (PFI>6 months)
    c. Pazienti platino sensibili che non possono o non sono disposte a ricevere un altro trattamento a base di platino;
    4. Malattia misurabile e valutabile secondo criteri RECIST 1.1
    (Pazienti con solo aumento di CA125, senza riscontro radiologico di malattia, sono esclusi);
    5. ECOG performance status 0 o 1;
    6. Nessun limite al numero di precedenti linee di trattamento ricevute,precedenti trattamenti con PARP inibitori sono concessi;
    7. Left Ventricular Ejection Fraction (LVEF) ≥ valore limite inferiore di normalità istituzionale;
    8. Aspettativa di vita di almeno 3 mesi;
    9. Adeguate funzionalità d’organo, definite come di seguito:
    - Emopoietica; Neutrofili in valore assoluto ≥ 1,500/mm3; Piastrine ≥ 100,000/mm3; Emoglobina ≥ 9 g/dl
    - Epatica; AST e ALT ≤ 1.5 x ULN(upper limit normal)* ; Fosfatasi Alcalina ≤ 2.5 x ULN* ; Bilirubina ≤ 1.5 x ULN N.B.: * ≤ 3 x ULN se presenza di metastasi epatiche
    - Renale; Creatinine Clearance ≥ 45 ml/min o Creatinina sierica ≤1.5 x ULN
    - Albumina >2.5 g/dl;
    10. Nessuna altra malignità di rilevanza prognostica negli ultimi 3 anni, fatta eccezione per carcinoma in situ della cervice o carcinoma basocellulare (pazienti con precedente malignità possono essere arruolati dopo conferma di non evidenza di malattia negli ultimi 3 anni);
    11. Firma del consenso informato;
    12. Recupero delle tossicità acute relative a trattamenti precedenti.
    13. Per i farmaci del braccio standard, consultare anche le informazioni del centro clinico in merito alle avvertenze, precauzioni e controindicazioni
    E.4Principal exclusion criteria
    1. Prior exposure to trabectedin
    2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
    3. Subjects with borderline ovarian cancer, ie. Subject with low malignant potential tumors are excluded
    4. Less than 2 reported responses to platinum (i.e. subsequent recurrences at least 6 months after the first and the second platinum based
    treatment), unless BRCA mutation is documented.
    5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy
    6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3
    years or longer
    7. Known clinically relevant CNS metastases, unless treated and asymptomatic
    8. Other serious illnesses, such as:
    a. Congestive heart failure or angina pectoris, myocardialinfarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias.
    b. Psychiatric disorder that prevents compliance with protocol.
    c. Active viral hepatitis; or chronic liver disease.
    d. Active infection.
    e. Any other unstable medical conditions.
    1. Precedente trattamento con trabectedina;
    2. Ipersensibilità nota ad uno qualsiasi dei componenti della formulazione i.v. di trabectedina o del desametasone;
    3. Sono esclusi i soggetti con carcinoma ovarico borderline, ad esempio pazienti con tumori maligni a basso potenziale;
    4. Almeno 2 risposte a precedenti terapie a base di platino (i.e. recidiva di malattia ad almeno 6 mesi dalla linea di terapia a base di platino), ad eccezione di mutazione BRCA nota;
    5. Almeno 4 settimane dall’ultima dose di terapia con qualsiasi terapia antitumorale sistemica;
    6. Storia di precedente tumore (ad eccezione del carcinoma in situ della cervice o carcinoma basocellulare adeguatamente trattato) se non in remissione da almeno 3 o più anni;
    7. Presenza di metastasi al SNC, se non asintomatiche ed adeguatamente trattate;
    8. Altre malattie gravi, quali:
    a. Scompenso cardiaco congestizio o angina pectoris; infarto del miocardio nell’anno precedente; ipertensione incontrollata o aritmia;
    b. Qualsiasi Condizione psicologica che ostacoli la compliance del protocollo;
    c. Epatite virale attiva o malattia epatica cronica;
    d. Infezioni attive;
    e. Qualsiasi altra condizione medica instabile.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to compare the treatment groups in terms of overall survival (OS)
    L’obiettivo primario è quello di comparare i gruppi di trattamento in termini di overall survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS will be measured from the date of randomization to death due to any cause
    L’OS sarà misurato dalla data dell’inizio del trattamento alla data del decesso avvenuto per qualsiasi causa
    E.5.2Secondary end point(s)
    Progression free survival (PFS) In case of CA 125 progression according to GCIG criteria is documented, a confirmatory CT scan and a radiological CT progression will be required.
    Radiological response rate
    Duration of response
    CA-125 response rate per GCIG and change in CA-125
    Toxicity profile
    Quality of life will be evaluated by QLQ-C30 and QLQ-OV28 questionnaires
    Intervallo libero da progressione (PFS). In caso di documentata progressione di CA125 secondo criteri GCIG, è richiesta una conferma radiologica di progressione
    Risposta radiologica
    Durata della risposta
    Risposta sierologica del marcatore CA-125 secondo i criteri GCIG
    Tossicità
    Qualità di vita mediante la compilazione di questionari QLQ-C30 e QLQ-OV28
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS will be measured from the date of randomization to the date of first observed disease progression (relapse) or the date of death due to any cause (if before progression).
    radiological assessment will be perform every 10 weeks ± 1 week
    time between the end of treatment (except for disease progression) and subsequent relapse
    CA-125 will be assessed at baseline and every day 1 of every cycle
    Toxicity will be evaluated during all treatment up to 30 days after the last treatment dose
    Quality of Life assessments are required at: Baseline, every 3 chemotherapy cycles and at the end of chemotherapy (either at progression or after the last cycle of chemotherapy if patient refuse to continue treatment)
    La PFS sarà misurata dalla data dall’inizio del trattamento alla data della prima progressione osservata o alla data del decesso se avvenuto per qualsiasi causa prima della progressione
    la valutazione radiologica sarà effettuata ogni 10 settimane ± 1 settimana
    tempo intercorso fra la fine del trattamento (se non per progressione di malattia) e la successiva recidiva
    Il CA-125 sarà valutato al baseline e al giorno 1 di ogni ciclo
    La tossicità sarà valutata durante tutto il trattamento fino a 30 giorni dopo l'ultimo trattamento ricevuto
    La compilazione del questionari di qualità di vita è richiesta al Baseline, ogni 3 cicli di Chemioterapia e alla fine della chemioterapia (alla progressione o dopo l'ultimo ciclo di chemioterapia se il paziente rifiuta di continuare il trattamento)
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned29
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA30
    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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state244
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 244
    F.4.2.2In the whole clinical trial 244
    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)
    The standard of care in prectice at the investigator site
    Lo standard terapeutico usato nella normale pratica clinica
    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 Decision2015-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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