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    Summary
    EudraCT Number:2021-002924-18
    Sponsor's Protocol Code Number:CYC065-101
    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:2021-07-20
    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 number2021-002924-18
    A.3Full title of the trial
    A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma
    Estudio en fase I/II, abierto y multicéntrico para investigar la seguridad, farmacocinética y eficacia de fadraciclib (CYC065), un inhibidor de CDK2/9 oral, en sujetos con tumores sólidos y linfoma avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma
    Estudio en fase I/II, abierto y multicéntrico para investigar la seguridad, farmacocinética y eficacia de fadraciclib (cyc065), un inhibidor de cdk2/9 oral, en sujetos con tumores sólidos avanzados y linfoma
    A.4.1Sponsor's protocol code numberCYC065-101
    A.5.4Other Identifiers
    Name:INDNumber:126182
    Name:US FDA INDNumber:126182
    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 SponsorCyclacel Pharmaceuticals
    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 supportCyclacel Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCyclacel Pharmaceuticals
    B.5.2Functional name of contact pointJulius Huang
    B.5.3 Address:
    B.5.3.1Street Address200 Connell Drive #1500
    B.5.3.2Town/ cityBerkeley Heights
    B.5.3.3Post codeNJ 07922
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908517 7330
    B.5.6E-mailjhuang@cyclacel.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 nameFadraciclib
    D.3.2Product code CYC065
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFadraciclib
    D.3.9.1CAS number 1315571-33-5
    D.3.9.2Current sponsor codeCYC065
    D.3.9.4EV Substance CodeSUB204099
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Endometrial cancer, Ovarian cancer, Biliary tract cancer, Hepatocellular carcinoma, B-cell lymphoma, T-cell lymphoma, Metastatic colorectal cancer, Breast cancer (metastatic HER-2 refractory, Hormone receptor +, HER-2 negative, and MBC post-CDK4/6 inhibitor, Triple-negative)
    Basket cohort: tumor types that are suspected to have a related mechanism of action and are not included in previous groups
    Cáncer de endometrio, cáncer de ovario, cáncer de las vías biliares, carcinoma hepatocelular (CHC), linfoma de linfocitos B, linfoma de linfocitos T, cáncer colorrectal metastásico, cáncer de mama (HER-2 metastásico refractario, receptor hormonal +, HER-2 negativo e inhibidor de MBC post-CDK4 / 6, triple negativo)
    Cohorte de cesta: tipos de tumores que se sospecha que tienen un mecanismo de acción relacionado y no están incluido en los grupos anteriores
    E.1.1.1Medical condition in easily understood language
    Endometrial cancer, Ovarian cancer, Biliary tract cancer, Hepatocellular carcinoma, B-cell lymphoma, T-cell lymphoma, Metastatic colorectal cancer, Breast cancer, Other solid tumors
    Cáncer de endometrio/ovario, cáncer de vías biliares, carcinoma hepatocelular, linfoma de linfocitos B, linfoma de linfocitos T, cáncer colorrectal metastásico, cáncer de mama, otros tumores sólidos.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014735
    E.1.2Term Endometrial cancer NOS
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025734
    E.1.2Term Malignant neoplasm of biliary tract, part unspecified
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073071
    E.1.2Term Hepatocellular carcinoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003899
    E.1.2Term B-cell lymphoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10042971
    E.1.2Term T-cell lymphoma
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10083234
    E.1.2Term Hormone receptor positive breast cancer
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive breast cancer
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10083232
    E.1.2Term HER2 negative breast cancer
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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
    Phase 1:
    To determine the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of fadraciclib when administered orally twice daily (BID) in 28-day cycles in adult subjects with advanced solid tumors and lymphoma

    Phase 2:
    To evaluate preliminary efficacy of fadraciclib as measured by overall response rate (ORR) in subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma who have failed all standard therapies or for whom standard therapy does not exist
    Fase I:
    Determinar la dosis máxima tolerada (DMT) y/o la dosis recomendada para la fase II (DRF2) de fadraciclib cuando se administra por vía oral dos veces al día (2 v/d) en ciclos de 28 días en sujetos adultos con tumores sólidos avanzados y linfoma

    Fase II:
    Evaluar la eficacia preliminar de fadraciclib medida por la tasa de respuesta global (TRG) en sujetos con tumores sólidos avanzados o linfoma localmente avanzados, recurrentes o metastásicos confirmados histológicamente que no han respondido a todos los tratamientos estándar o para los que no existe un tratamiento estándar.
    E.2.2Secondary objectives of the trial
    Phase 1:
    - To assess safety and tolerability of fadraciclib
    - To investigate clinical pharmacokinetics (PK) of fadraciclib
    - To evaluate overall response rate (ORR) in subjects receiving fadraciclib

    Phase 2:
    - To assess the safety and tolerability of fadraciclib
    - To evaluate the ORR in subjects receiving fadraciclib
    Fase I:
    - Evaluar la seguridad y tolerabilidad de fadraciclib
    - Investigar la farmacocinética (FC) clínica de fadraciclib
    - Evaluar la tasa de respuesta global (TRG) en sujetos que reciben fadraciclib

    Fase II:
    - Evaluar la seguridad y tolerabilidad de fadraciclib
    - Evaluar la TRO en sujetos que reciben fadraciclib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females aged ≥ 18 years
    2. Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
    3. ECOG performance status of 0 or 1
    4. Subjects must have laboratory values as stated in the protocol
    5. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval
    6. Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels.
    7. Able to agree to and sign the informed consent and to comply with the protocol.
    1.Hombre o mujer, ≥18 años.
    2.Sujetos con cáncer avanzado confirmado histológica o citológicamente que han progresado con el tratamiento de referencia (o no han podido tolerarlo) o para quienes no se dispone de tratamiento de referencia contra el cáncer.
    3.Estado funcional según el Grupo Oncológico Cooperativo del Este de Estados Unidos (ECOG) de 0 o 1.
    4.Los sujetos deben tener los valores analíticos que se detallan en el protocolo
    5.Las MEF deben tener una prueba de embarazo negativa (en orina o suero) en los 7 días previos al inicio del fármaco del estudio. Tanto hombres como mujeres deben aceptar utilizar métodos anticonceptivos eficaces durante el estudio (antes de recibir la primera dosis y durante 6 meses después de la última dosis) si es posible concebir durante este intervalo.
    6.Los sujetos deben ser capaces de tragar y retener la medicación administrada por vía oral, y no deben presentar anomalías gastrointestinales (GI) de importancia clínica que puedan alterar la absorción, como síndrome de malabsorción o resección importante del estómago o los intestinos.
    7.Capaz de aceptar y firmar el formulario de consentimiento informado y cumplir con el protocolo.
    E.4Principal exclusion criteria
    1. Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible.
    2. Subjects who have not received vaccines for SARS-COV-2 within last 3 months and have suspected signs and symptoms of COVID-19 or a recent history (within 14 days) of contact with any COVID-19 positive subject/isolation/quarantine or subjects with confirmed COVID-19.
    3. Subjects with a history of another primary malignancy, please see additional details in the protocol.
    4. Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results. See additional details in the protocol.
    5. Diseases that significantly affect GI absorption of fadraciclib
    6. Subjects who have impaired cardiac function or clinically significant cardiac disease, see additional details in the protocol.
    7. Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or GI perforation within 6 months of enrollment
    8. Presence of an active infection requiring intravenous antibiotics
    9. Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism
    10. Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). In subjects with a history of HBV, hepatitis B core antibody testing is required and if positive, then HBV DNA testing will be performed, and if positive, the subject will be excluded. For subjects with HCV Ab positive, HCV viral load must be below the limit of quantification.
    11. Chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 3 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy.
    12. Major surgery/surgical therapy for any cause within 4 weeks of the first dose
    1.Sujetos con antecedentes de metástasis cerebrales o con signos o síntomas atribuibles a las metástasis cerebrales y que no han sido evaluados mediante imágenes radiológicas para descartar la presencia de metástasis cerebrales. Los sujetos con metástasis cerebrales tratadas que sean asintomáticas y hayan estado clínicamente estables durante al menos 4 semanas serán aptos
    2.Sujetos que no hayan recibido vacunas contra el SARS-COV-2 en los últimos 3 meses y tengan sospecha de signos y síntomas de nueva infección por coronavirus (COVID-19) o antecedentes recientes (en los últimos 14 días) de contacto con un sujeto positivo para COVID-19/aislamiento/cuarentena o con COVID-19 confirmada.
    3.Sujetos con antecedentes de otra neoplasia maligna primaria, por favor ver más detalles en el protocolo.
    4.Cualquier otra afección médica o psiquiátrica aguda o crónica de importancia clínica o cualquier anomalía de laboratorio que pueda aumentar el riesgo asociado a la administración del fármaco del estudio o interferir con la interpretación de los resultados del estudio, por favor ver más detalles en el protocolo
    5.Enfermedades que afectan significativamente a la absorción GI de fadraciclib
    6.Insuficiencia cardiovascular o enfermedad cardiovascular de importancia clínica, por favor ver más detalles en el protocolo
    7.Presencia de enfermedad intestinal inflamatoria crónica activa (colitis ulcerosa, enfermedad de Crohn) o perforación GI en los 6 meses anteriores a la inscripción
    8.Presencia de infección activa que requiere antibióticos por vía intravenosa (i.v.)
    9.Presencia de antecedentes conocidos de virus de la inmunodeficiencia humana-1/2 con carga viral no controlada y en medicamentos que podrían interferir con el metabolismo
    10.Presencia de virus de la hepatitis B (VHB) o virus de la hepatitis C (VHC) activos En los sujetos con antecedentes de VHB, se requiere la prueba de anticuerpos contra el núcleo de la hepatitis B (HBcAb) y, si es positiva, se realizará la prueba de ADN del VHB y, si es positiva, se excluirá al sujeto. Para los sujetos con VHC Ab positivo, la carga viral del VHC debe estar por debajo del límite de cuantificación.
    11.Quimioterapia, tratamiento biológico, tratamiento dirigido, inmunoterapia, radioterapia de campo extendido o fármacos en investigación dentro de las 5 semividas o 3 semanas (lo que sea más corto) antes de administrar la primera dosis del fármaco del estudio el día 1 o a aquellos que no se hayan recuperado de los efectos secundarios de dicho tratamiento.
    12. Cirugía mayor o tratamiento quirúrgico por cualquier causa en las 4 semanas anteriores a la primera dosis
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    The incidence rate of dose-limiting toxicities (first cycle only) at each dose level

    Phase 2:
    ORR according to Response Evaluation Criteria in Solid Tumors: RECIST guidelines (Lugano Criteria for lymphoma, mSWAT for CTCL) for each tumor type
    Fase 1:
    La tasa de incidencia de toxicidades limitantes de la dosis (solo en el primer ciclo) en cada nivel de dosis.

    Fase 2:
    TRG según los Criterios de evaluación de respuesta en tumores sólidos: directrices RECIST (Criterios de Lugano para linfoma, mSWAT para CTCL) para cada tipo de tumor
    E.5.1.1Timepoint(s) of evaluation of this end point
    At predetermined time points described in the protocol
    En puntos de tiempo predeterminados descritos en el protocolo
    E.5.2Secondary end point(s)
    - Safety
    - Disease control rate (DCR)
    - Response rate as per Lugano Criteria for lymphoma, mSWAT for CTCL
    - Progression-free survival
    - Duration of response
    - Overall survival
    - PK in Phase 1
    - Seguridad
    - Tasa de control de enfermedades (TCE)
    - Tasa de respuesta según los Criterios de Lugano para linfoma, mSWAT para CTCL
    - Supervivencia libre de progresión
    - Duración de la respuesta
    - Sobrevivencia promedio
    - FC en la Fase 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    At predetermined time points described in the protocol
    En puntos de tiempo predeterminados descritos en el protocolo
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose-escalation
    Incremento de dosis
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Korea, Republic of
    United States
    Spain
    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
    Última Visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months32
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 248
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3
    F.4.2.2In the whole clinical trial 354
    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 Decision2021-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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