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    The EU Clinical Trials Register currently displays   43853   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2015-000106-19
    Sponsor's Protocol Code Number:GO29689
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-000106-19
    A.3Full title of the trial
    A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF GDC-0810 VERSUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ADVANCED OR METASTATIC ER+/HER2- BREAST CANCER RESISTANT TO AROMATASE INHIBITOR THERAPY
    ESTUDIO DE FASE II, ABIERTO, ALEATORIZADO DE GDC 0810 FRENTE A FULVESTRANT EN MUJERES POSTMENOPÁUSICAS CON CÁNCER DE MAMA AVANZADO O METASTÁSICO ER+/HER2- RESISTENTE A TERAPIA INHIBIDORA DE LA AROMATASA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of GDC-0810 versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant To Aromatase Inhibitor Therapy
    Estudio de GDC-0810 frente a fulvesntrant en mujeres postmenopáusicas con cáncer de mama avanzado o metastásico ER+/Her- resistente a terapia inhibidora de la aromatasa.
    A.4.1Sponsor's protocol code numberGO29689
    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 SponsorGenentech, Inc
    B.1.3.4CountryUnited States
    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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGDC-0810
    D.3.2Product code 705-6118/F01-01
    D.3.4Pharmaceutical form Tablet
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGDC-0810 (RO7056118)
    D.3.9.3Other descriptive nameRO7056118
    D.3.9.4EV Substance CodeSUB171190
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 FASLODEX
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFULVESTRANT
    D.3.9.1CAS number 129453-61-8
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Advanced or Metastatic ER+/HER2- Breast Cancer
    Cáncer de mama avanzado o metastásico ER+/HER2-
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread beyond the breast tissue and surrounding lymph nodes and tests positive for estrogen receptors and negative for human epidermal growth factor receptor-2
    Cáncer de mama que se ha extendido más alla del tejido de la mama y gáglios linfáticos circundantes y resultado positivo en test para receptores de estrógenos y negativo Her2.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? To evaluate the efficacy of GDC-0810 compared with fulvestrant in the intent to treat (ITT) population as measured by progression free survival (PFS)
    ? To evaluate the efficacy of GDC-0810 compared with fulvestrant in the estrogen receptor 1 (ESR1) mutant population as measured by PFS
    - Evaluar la eficacia de GDC-0810 en comparación con fulvestrant en la población con intención de tratar (IDT) medida según la supervivencia sin progresión (SSP).
    - Evaluar la eficacia de GDC-0810 en comparación con fulvestrant en la población con mutaciones detectables en el ESR1 medida según la SSP
    E.2.2Secondary objectives of the trial
    ? To assess the clinical activity of GDC-0810 versus fulvestrant, as measured by objective response rate (ORR), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS)
    ? To evaluate the safety and tolerability of GDC-0810 compared with fulvestrant, focusing on the nature, frequency, and severity of serious and non-serious adverse events
    ? To assess the pharmacokinetics of GDC-0810 in patients with advanced or metastatic breast cancer (MBC) resistant to aromatase inhibitor (AI) therapy
    - Evaluar la actividad clínica de GDC-0810 frente a fulvestrant, medida según la tasa de respuesta objetiva (TRO), la duración de la respuesta objetiva (DRO), la tasa de beneficio clínico (TBC) y la supervivencia global (SG).
    - Evaluar la seguridad y la tolerabilidad de GDC-0810 en comparación con fulvestrant, con especial atención en la naturaleza, la frecuencia y la gravedad de los acontecimientos adversos graves y no graves.
    - Evaluar la farmacocinética de GDC-0810 en pacientes con cáncer de mama avanzado o metastásico resistente al tratamiento con inhibidor de la aromatasa (IA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Postmenopausal women with histologically or cytologically confirmed invasive, estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) (defined by local guidelines) metastatic or inoperable (not amenable to resection or other local therapy with curative intent), locally advanced breast cancer
    - Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
    - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
    - Radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or MBC
    - Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
    - Eastern Cooperative Oncology Group Performance Status of 0 or 1
    - Adequate hematologic and end-organ function
    - Mujeres posmenopáusicas con cáncer de mama ER + /HER2- (definido según las directrices locales) metastásico o irresecable (no se puede extirpar ni intentar curar con cualquier otro tratamiento local), invasivo o localmente avanzado y diagnosticado de forma citológica o histológica.
    - Pacientes a las que se recomienda el tratamiento endrocrino (p. ej., fulvestrant) y para las que no está indicado el tratamiento con quimioterapia citotóxica en el momento del acceso al estudio, según las directrices del tratamiento locales y nacionales.
    - Pruebas objetivas/radiológicas de recurrencia o progresión hasta el tratamiento generalizado más reciente para el cáncer de mama.
    - Pruebas objetivas/radiológicas de recurrencia o progresión del cáncer de mama durante el tratamiento complementario con un IA o en un período posterior de 6 meses tras la finalización de este, o bien progresión durante el tratamiento con IA anterior para cáncer de mama localmente avanzado o metastásico o en un período posterior de 1 mes tras la finalización de este.
    - Las pacientes deben tener una enfermedad mensurable según el sistema RECIST versión 1.1 o inmensurable, enfermedad evaluable con al menos una lesión ósea evaluable según RECIST versión 1.1 en función de las exploraciones radiológicas realizadas en el plazo de 28 días del día 1 del ciclo 1.
    - Niveles de calidad de vida de 0 o 1 de ECOG
    - Actividad suficiente hematológica y del órgano terminal
    E.4Principal exclusion criteria
    - HER2 positive disease (immunohistochemistry [IHC] 3+ staining, fluorescence in situ hybridization [FISH] positive, and/or chromogenic in situ hybridization [CISH] positive)
    - Prior treatment with fulvestrant
    - Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1
    - Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1
    - Prior treatment with >1 cytotoxic chemotherapy regimens or >2 endocrine therapies for advanced or metastatic disease
    - Ongoing, acute treatment-related toxicity that has not resolved to Grade <=1 or been deemed stable by the investigator
    - Concurrent hormone replacement therapy
    - Known untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
    - History of other malignancy within the previous 5 years
    - Inability or unwillingness to swallow pills or receive intramuscular injections
    - Clinically significant cardiac or pulmonary dysfunction
    - Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgery during the course of study treatment
    - Cáncer HER2 positivo (tinción inmunohistoquímica con 3 +, hibridación fluorescente in situ [FISH] positiva, o hibridación cromogénica in situ [CISH] positiva).
    - Tratamiento previo con fulvestrant.
    - Tratamiento oncológico previo en el plazo de dos semanas antes del día 1 del ciclo 1.
    - Radioterapia previa en el periodo de dos semanas antes del día 1 del ciclo 1.
    - Tratamiento previo con > 1 tratamiento de quimioterapia citotóxica o > 2 tratamientos endocrinos para cáncer metastásico o avanzado.
    - Toxicidad aguda y continua relacionada con el tratamiento que no se ha resuelto hasta el grado <= 1 o se ha considerado estable por parte del investigador.
    - Hormonoterapia restitutiva simultánea.
    - Metástasis conocidas del sistema nervioso central (SNC) activa o sin tratar (que progresan o requieren anticonvulsivos o corticoesteroides para el control sintomático);
    - Antecedentes de otros tumores malignos en los 5 años anteriores.
    - Incapacidad o negativa a tragar pastillas o recibir inyecciones i. m.
    - Disfunción pulmonar o cardíaca clínicamente significativa
    - Procedimiento quirúrgico importante o traumatismo significativo en un plazo de 28 días anteriores al día 1 del ciclo 1 o previsión de un procedimiento quirúrgico importante durante el ciclo del tratamiento en estudio.
    E.5 End points
    E.5.1Primary end point(s)
    PFS as determined by the investigator per RECIST v1.1
    SSP determinada por parte del investigador según el sistema RECIST versión 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 months
    26 meses
    E.5.2Secondary end point(s)
    1. OS
    2. ORR (partial response [PR] plus complete response [CR]) as determined by the investigator per RECIST v1.1
    3. DOR as determined by the investigator per RECIST v1.1
    4. CBR
    5. Incidence of adverse events and serious adverse events
    6. Clinically significant changes in vital signs, physical findings, and clinical laboratory results
    7. Apparent clearance, volume of distribution, absorption rate constant of GDC-0810
    1.SG
    2. TRO (Remisión parcial (RP) más remisión completa (RC) determinda por parte del investigador según sistema RECIST 1.1.
    3. DRO determinada por parte del investigador según el sistema RECIST versión 1.1.
    4. TBC
    5. Incidencia de aconteciminetos adversos y acontecimientos adversos graves.
    6. Cambios clínicamente significativos de las constantes vitales, los datos obtenidos en la exploración física y los resultados clínicos del laboratorio.
    7. Aclaramiento evidente, el volumen de distribución, la constante de la tasa de absorción de GDC-0810
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6. 26 months
    7. Predose and 3 hours postdose at Cycle 1 Day 1 and Cycle 3 Day 1
    1-6. 26 meses.
    7. Pre dosis y 3 horas post dosis en Ciclo 1 Día 1 y Ciclo 3 Día 1.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Germany
    Korea, Republic of
    Spain
    United Kingdom
    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 end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis (i.e., progression-free survival) or safety follow-up is received from the last patient, whichever occurs later, or when the Sponsor decides to stop the study.
    La finalización del estudio se define como la fecha en la que se produce la última visita, de la última paciente o la fecha en la que se recibe el último punto de datos necesario para el análisis estadístico (es decir, SSP) o el seguimiento de la seguridad de la última paciente, lo que ocurra más tarde, o cuando el promotor decide detener el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 152
    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 Sponsor will offer post-trial access to the study drug (GDC-0810) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    El promotor ofrecerá acceso al fármaco en estudio (GDC-0810) después del ensayo de manera gratuita a todas las pacientes idóneas de acuerdo con la política global de Roche sobre el acceso continuo al fármaco en etapa de investigación clínica.
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
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