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   43873   clinical trials with a EudraCT protocol, of which   7293   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:2012-001050-25
    Sponsor's Protocol Code Number:CAUY922A2207
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-30
    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 number2012-001050-25
    A.3Full title of the trial
    A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment
    Studio multicentrico, randomizzato, in aperto, di Fase II per valutare l’efficacia di AUY922 rispetto a pemetrexed o docetaxel in pazienti affetti da NSCLC con mutazioni di EGFR che sono progrediti durante un precedente trattamento con un farmaco inibitore del recettore tirosino-chinasico del fattore di crescita epidermoidale (EGFR TKI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations
    Studio randomizzato, in aperto, di Fase II per valutare l’efficacia di AUY922 rispetto a pemetrexed o docetaxel in pazienti affetti da NSCLC con mutazioni di EGFR
    A.4.1Sponsor's protocol code numberCAUY922A2207
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number02-96541
    B.5.5Fax number02-9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 No
    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 nameNA
    D.3.2Product code AUY922
    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.3.9.2Current sponsor codeAUY922
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ALIMTA*1FL POLV 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA SpA
    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.3.4Pharmaceutical 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 INNPEMETREXED DISODIUM
    D.3.9.1CAS number 150399-23-8
    D.3.9.4EV Substance CodeSUB03669MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNDOCETAXEL TRIHYDRATE
    D.3.9.1CAS number 148408-66-6
    D.3.9.4EV Substance CodeSUB21602
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non small-cell lung cancer (NSCLC)
    Carcinoma polmonare non a piccole cellule (Non Small Cell Lung Cancer – NSCLC)
    E.1.1.1Medical condition in easily understood language
    lung cancer
    Carcinoma polmonare
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 compare PFS in patients with advanced NSCLC whose tumors harbor EGFR activating mutations and have progressed on EGFR TKI treatment treated with AUY922 versus pemetrexed or docetaxel.
    Confrontare la sopravvivenza libera da progressione (Progression Free Survival - PFS) in pazienti, il cui tumore presenta mutazioni attivanti dell’EGFR e che sono progrediti durante il trattamento con EGFR TKI, trattati con AUY922 rispetto a pemetrexed o docetaxel,
    E.2.2Secondary objectives of the trial
    - To compare OS between the treatment arms. - To compare the Overall Response Rate (ORR) between the treatment
    arms. - To compare the Disease Control Rate (DCR) duration between the treatment arms. - To compare Time to Progression (TTP) between the treatment arms. - To compare Duration of Response (DOR) between the treatment arms.
    - To evaluate safety and tolerability of administering AUY922 in the treatment of NSCLC compared to pemetrexed or docetaxel.
    - Confrontare la sopravvivenza globale (Overall Survival - OS), il tasso di risposta globale (Overall Response Rate - ORR), il tasso di controllo di malattia (Disease Control Rate - DCR), il tempo alla progressione (Time To Progression - TTP) e la durata della risposta (Duration Of Response - DOR) tra i gruppi di trattamento. - Valutare la tossicità e la tollerabilità della somministrazione di AUY922 nel trattamento dell’NSCLC rispetto a pemetrexed o docetaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
    2. Patients must have EGFR gene mutation in their tumors.
    3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented
    progression according to RECIST.
    4. Patients must be 18 years or older and able to sign Informed Consent.
    5. Patients must be suitable and willing to undergo mandatory baseline biopsy according to treating institution’s own guidelines and requirements for such procedure. No baseline biopsy is required for patients with known resistance mechanisms to EGFR TKI and available tumor material
    6. WHO performance status of 0-1.
    7. Measurable disease according to RECIST v.1.1 (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
    •Pazienti con carcinoma polmonare non a piccole cellule, documentato istologicamente o citologicamente, localmente avanzato (stadio IIIB che non si possa sottoporre a una modalità combinata di trattamento) o ricorrente o metastatico (stadio IV).
    •Pazienti con tumore che presenta mutazione genetica dell’EGFR.
    •Pazienti con beneficio clinico documentato (CR, PR o SD per 6 mesi o più) durante il trattamento precedente con EGFR TKI (ad es. erlotinib o gefitinib) seguito da progressione documentata in base ai criteri RECIST.
    •Pazienti di età uguale o superiore a 18 anni in grado di firmare il consenso informato.
    •Pazienti idonei e disponibili a sottoporsi alla biopsia obbligatoria all’ingresso nello studio, in conformità alle linee guida proprie dell’ospedale di riferimento per il trattamento e ai requisiti per tale procedura. Non sono richieste biopsie all’ingresso nello studio per i pazienti con noti meccanismi di resistenza a EGFR TKI e materiale tumorale disponibile.
    •Punteggio WHO Performance Status 0-1.
    •Malattia misurabile secondo i criteri RECIST v. 1.1 (le lesioni irradiate non possono essere considerate misurabili a meno che non siano chiaramente progredite dalla radioterapia)
    E.4Principal exclusion criteria
    1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of
    this study.
    2. Patients who have received any antineoplastic treatment between EGFR TKI discontinuation and study start.
    3. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory.
    4. Patients who have received EGFR TKI (e.g. erlotinib, gefitinib) within ≤ 5 half-lives of the agent or active metabolites of the of starting the study. All associated toxicities (with
    the exception of alopecia) should be resolved to baseline or less prior to treatment start.
    5. Patients who received radiation therapy for management of local disease within four weeks (RT for palliative pain management is allowed). All associated toxicities (with the
    exception of alopecia) should be resolved to grade 1 or less prior to treatment start.
    6. Prior treatment with an HSP90 inhibitor
    •Pazienti che hanno ricevuto più di due precedenti linee di terapia per malattia avanzata. La chemioterapia somministrata come trattamento adiuvante più di sei mesi prima dell’arruolamento nello studio non è considerata una precedente linea di trattamento per lo scopo di questo studio.
    •I pazienti non devono aver ricevuto un trattamento anti-neoplastico tra l’interruzione di EGFR TKI e l’inizio dello studio.
    •Evidenza di compressione del midollo spinale o evidenza attuale di metastasi del sistema nervoso centrale. È obbligatoria una TAC/RMN cerebrale di screening.
    •I pazienti non devono aver ricevuto l’agente o i metaboliti attivi per EGFR TKI (ad es. erlotinib, gefitinib) entro ≤ 5 emivite dall’inizio dello studio. Tutte le tossicità associate (ad eccezione di alopecia) devono essere risolte al basale o precedentemente prima dell’inizio del trattamento.
    •I pazienti non devono essere stati sottoposti a radioterapia per la gestione della malattia locale nelle quattro settimane precedenti. Tutte le tossicità associate (ad eccezione di alopecia) devono essere risolte a grado 1 o meno prima dell’inizio del trattamento.
    •Precedente trattamento con un inibitore HSP90.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) based on local investigator assessment
    per RECIST 1.1
    Sopravvivenza libera da progressione (Progression Free Survival - PFS) basata sulla valutazione dello sperimentatore del centro in accordo ai criteri RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    durarion of the treatment
    per tutta la durata del trattamento
    E.5.2Secondary end point(s)
    1. overall survival (OS)
    2. overall response rate (ORR)
    3. disease control rate (DCR)
    4. time to progression (TTP)
    5. duration of response (DOR), all above based on local investigator assessment per RECIST 1.1.
    6. rate of adverse events (AEs)
    7. rate of serious adverse events (SAEs)
    1. sopravvivenza globale (Overall Survival - OS)
    2. tasso di risposta globale (Overall Response Rate - ORR)
    3. tasso di controllo di malattia (Disease Control Rate - DCR).
    4. tempo alla progressione (Time To Progression - TTP).
    5. durata della risposta (Duration Of Response - DOR), basati sulla valutazione dello sperimentatore del centro secondo i criteri RECIST 1.1.
    6. tasso di eventi avversi (Adverse Event – AE).
    7. tasso di eventi avversi seri (Serious Adverse Event – SAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from randomization to death
    2-7. treatment duration
    1. dalla randomizzazione alla morte
    2-7. per tutta la durata del 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    compare efficacy of AUY922 versus pemetrexed or docetaxel
    Confrontare l'efficacia di AUY922 rispetto a pemetrexed e docetaxel
    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 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Hong Kong
    Israel
    Korea, Republic of
    Singapore
    Taiwan
    United States
    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
    The study will continue until one year past last patient treatment
    unless survival follow up period has already been completed.
    Lo studio continuerà fino a un anno dopo la data dell'ultimo trattamento dell'ultimo paziente a meno che il periodo di follow up per la sopravvivenza non sia già stato completato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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: 0
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 120
    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)
    as per clinical practice
    secondo 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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Wed May 08 02:15:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA