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   43976   clinical trials with a EudraCT protocol, of which   7312   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:2022-000493-26
    Sponsor's Protocol Code Number:D533BC00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-000493-26
    A.3Full title of the trial
    A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY
    Estudio de fase III, abierto, aleatorizado y multicéntrico, de ceralasertib más durvalumab frente a docetaxel en pacientes con cáncer de pulmón no microcítico avanzado o metastásico sin alteraciones genómicas aprovechables terapéuticamente y cuya enfermedad haya progresado durante o después del tratamiento previo con anti-PD-(L)1 y quimioterapia basada en el platino: LATIFY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ceralasertib plus durvalumab versus docetaxel for patients with advanced or metastatic non-small cell lung cancer
    Estudio de ceralasertib más durvalumab frente a docetaxel en pacientes con cáncer de pulmón no microcítico avanzado o metastásico
    A.3.2Name or abbreviated title of the trial where available
    LATIFY
    LATIFY
    A.4.1Sponsor's protocol code numberD533BC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryUnited States
    B.5.6E-mailInformation.Center@astrazeneca.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 nameCeralasertib 120 mg
    D.3.2Product code AZD6738
    D.3.4Pharmaceutical form Film-coated 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 INNCeralasertib
    D.3.9.1CAS number 1352226-88-0
    D.3.9.2Current sponsor codeAZD6738
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    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 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 Yes
    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.2.1.1.1Trade name Docetaxel
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameDocetaxel
    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
    D.3.9.1CAS number 114977-28-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 4
    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 nameCeralasertib 80 mg
    D.3.2Product code AZD6738
    D.3.4Pharmaceutical form Film-coated 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 INNCeralasertib
    D.3.9.1CAS number 1352226-88-0
    D.3.9.2Current sponsor codeAZD6738
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or thirdline therapy and without actionable genomic alterations
    Demostrar la superioridad de la terapia de combinación con ceralasertib más durvalumab respecto a docetaxel mediante la evaluación de la OS en participantes con NSCLC avanzado sin alteraciones genómicas aprovechables terapéuticamente tras la segunda o tercera línea de tratamiento
    E.2.2Secondary objectives of the trial
    -To demonstrate superiority of ceralasertib plus durvalumab(C&D)combination therapy relative to docetaxel by assessment of PFS.
    -To estimate the effectiveness of C&D combination therapy relative:
    -to docetaxel by assessment of ORR
    -to docetaxel by assessment of duration of response(DoR)
    -to docetaxel by assessment of time to response(TTR)
    -to docetaxel by assessment of disease control rate(DCR) at 18 weeks
    -to docetaxel by assessment of time to second progression or death(PFS2)
    -to docetaxel by assessment of OS at 12 months(OS12)
    -To assess participant-reported health-related quality of life(QoL)
    -To assess participant-reported physical functioning in participants treated with C&D combination therapy relative to docetaxel
    -To evaluate participant-reported treatment tolerability
    -To assess the PK of ceralasertib when administered in combination with durvalumab
    -To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
    -Demostrar la superioridad de la terapia de combinación con ceralasertib más durvalumab respecto a docetaxel mediante la evaluación de la PFS.
    -Estimar la efectividad de la terapia de combinación con C&D respecto a docetaxel mediante la evaluación:
    -de la ORR
    -de la duración de la respuesta
    -del tiempo hasta la respuesta
    -de la tasa de control de la enfermedad a las 18 semanas
    -del tiempo hasta la segunda progresión o la muerte
    -la evaluación de la OS a los 12 meses
    -Evaluar la calidad de vida relacionada con la salud comunicada por el participante
    -Evaluar el funcionamiento físico comunicado por los participantes tratados con la terapia de combinación de C&D respecto a docetaxel
    -Evaluar la tolerabilidad del tratamiento comunicada por el participante
    -Evaluar la farmacocinética de ceralasertib al ser administrado en combinación con durvalumab
    -Evaluar la seguridad y la tolerabilidad de la terapia de combinación de C&D respecto a docetaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be >/= 18 years at the time of screening.
    2. Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
    3. Documented EGFR and ALK wild-type status as determined at a local laboratory.
    4. Documented radiological PD whilst on or after receiving the most recent treatment regimen.
    5. Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
    6. ECOG/WHO performance status of 0 or 1.
    7. Adequate organ function and marrow reserve
    8. Minimum life expectancy of 12 weeks.
    9. Body weight > 30 kg and no cancer-associated cachexia.
    10. Negative pregnancy test (serum test) for WOCBP.
    1. Participante con edad >/= 18 años en el momento de la selección.
    2. Cáncer de pulmón no microcítico (non-small cell lung cancer, NSCLC), documentado histológica o citológicamente, localmente avanzado o metastásico según el Manual de Estadificación en Oncología Torácica de la IASLC, Versión 8.
    3. Estado de EGFR y ALK de tipo natural, documentado, según la determinación del laboratorio local.
    4. Progresión de la enfermedad (progression of disease, PD) radiológica documentada durante o después de recibir el régimen de tratamiento más reciente.
    5. Indicación de tratamiento de segunda o tercera línea y haber recibido tratamiento anti-PD-(L)1 y biquimioterapia con derivados del platino para NSCLC localmente avanzado o metastásico, ya sea por separado o en combinación.
    6. Estado funcional del ECOG/WHO de 0 o 1.
    7. Funcionalidad orgánica y reserva medular adecuadas
    8. Esperanza de vida mínima de 12 semanas.
    9. Peso corporal > 30 kg y sin caquexia neoplásica.
    10. Prueba de embarazo negativa (en suero) en las mujeres potencialmente fértiles.
    E.4Principal exclusion criteria
    1. Participant with mixed SCLC and NSCLC histology.
    2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease >/= 5 years before the first dose of study intervention.
    3. Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
    4. Active or prior documented autoimmune or inflammatory disorders.
    5. Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
    6. Participants:
    (a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
    (b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
    (c) Must not have experienced a Grade >/= 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
    (d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
    7. Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
    8. Participants who have received a prior ATR inhibitor.
    1. Participante con histología mixta de carcinoma pulmonar microcítico y no microcítico.
    2. Antecedentes de otra neoplasia maligna primaria, excepto que haya sido tratada con intención curativa y no haya mostrado actividad de la enfermedad >/= 5 años antes de la primera dosis del tratamiento del estudio.
    3. Efectos tóxicos (de grado > 2 de los CTCAE) persistentes del tratamiento antineoplásico previo.
    4. Trastornos autoinmunitarios o inflamatorios activos o previos documentados.
    5. Participantes que hayan recibido más de una línea de anti-PD-(L)1 previa, ya sea sola o en combinación.
    6. Los participantes:
    (a) No deben haber presentado toxicidad que condujera a la suspensión permanente del tratamiento anti-PD(L)1 previo.
    (b) Deben mostrar resolución completa de todos los acontecimientos adversos (adverse events, AE) presentes durante el tratamiento anti-PD(L)1 previo.
    (c) No deben haber presentado AE de origen inmunitario (immune-mediated adverse events, imAE) de grado >/= 3 ni AE neurológicos u oculares de tipo inmunitario de ningún grado durante el tratamiento anti-PD(L)1 previo.
    (d) No deben haber precisado inmunosupresión adicional distinta de corticosteroides para el tratamiento de un AE, no deben haber presentado reaparición de un AE en caso de reexposición y no deben precisar en la actualidad dosis de mantenimiento > 10 mg de prednisona o equivalente al día.
    7. Participantes que hayan recibido más de una línea previa de quimioterapia con derivados del platino para enfermedad metastásica.
    8. Participantes que hayan recibido un inhibidor de ATR previo.
    E.5 End points
    E.5.1Primary end point(s)
    - OS is defined as time from randomisation until the date of death due to any cause.
    - The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy.
    - The measure of interest is the HR of OS.
    - La OS se define como el tiempo transcurrido desde la aleatorización hasta la fecha de la muerte por cualquier causa.
    - La comparación incluirá a todos los participantes aleatorizados, independientemente de si el participante abandona la terapia a la que fue aleatorizado o recibe otro tratamiento antineoplásico.
    - La medida de interés es el cociente de riesgos instantáneos (hazard ratio, HR) de la OS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    time from randomisation until the date of death due to any cause
    tiempo desde la aleatorización hasta la fecha de la muerte por cualquier causa
    E.5.2Secondary end point(s)
    - To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, of duration of response (DoR), time to response (TTR), disease control rate (DCR) at 18 weeks, time to second progression or death (PFS2), OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant-reported physical functioning, participant-reported treatment tolerability.

    - To assess the PK of ceralasertib when administered in combination with durvalumab.

    - To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
    - Demostrar la superioridad de ceralasertib más durvalumab respecto al docetaxel, mediante la evaluación de la supervivencia sin progresión (progression free survival, PFS), la tasa de respuesta objetiva (overall response rate, ORR), la duración de la respuesta (duration of response, DoR), el tiempo hasta la respuesta (time to response, TTR), la tasa de control de la enfermedad (disease control rate, DCR) a las 18 semanas, el tiempo hasta la segunda progresión o la muerte (time to second progression or death, PFS2), la supervivencia global (overall survival) a los 12 meses (OS12), la calidad de vida (quality of life, QoL) relacionada con la salud comunicada por el participante, el funcionamiento físico comunicado por el participante y la tolerabilidad del tratamiento comunicada por el participante.

    - Evaluar la farmacocinética (pharmacokinetic, PK) del ceralasertib administrado en combinación con durvalumab.

    - Evaluar la seguridad y la tolerabilidad del tratamiento con ceralasertib más durvalumab en comparación con docetaxel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The tumour response endpoints (PFS, ORR, DoR and TTR) will be driven from randomisation up until progression, or the last evaluable assessment in the absence of progression (up to three years).

    -Plasma concentration of ceralasertib and sparse PK parameters such as peak concentration and trough, as data allow.

    - Safety and tolerability will be evaluated in terms of TEAEs, vital signs, clinical laboratory results, and ECGs.
    - Los criterios de valoración de la respuesta tumoral (PFS, ORR, DoR y TTR) se analizarán desde la aleatorización hasta la progresión o, en ausencia de esta, hasta el último examen evaluable (hasta tres años).

    - Concentración plasmática de ceralasertib y parámetros farmacocinéticos del muestreo disperso, como las concentraciones máxima y mínima, si los datos lo permiten.

    - La seguridad y la tolerabilidad se evaluarán mediante los acontecimientos adversos surgidos durante el tratamiento (treatment-emergent adverse events, TEAE), las constantes vitales, los resultados de laboratorio y los ECG.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Hong Kong
    India
    Japan
    Korea, Republic of
    Taiwan
    United States
    France
    Poland
    Netherlands
    Romania
    Spain
    Germany
    Italy
    Belgium
    Hungary
    Serbia
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally (including OS determination).
    El fin del estudio viene definido por la fecha de la última visita del último participante en el estudio o el último procedimiento programado indicado en el calendario de actividades del último participante en el estudio, en todos los países (incluida la determinación de la OS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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 months2
    E.8.9.2In all countries concerned by the trial days7
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 208
    F.4.2.2In the whole clinical trial 580
    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
    Ninguno
    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 Decision2022-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA