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    EudraCT Number:2021-002322-24
    Sponsor's Protocol Code Number:SOLTI-1911
    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:2021-11-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-002322-24
    A.3Full title of the trial
    Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS)
    Ribociclib y terapia endocrina en neoadyuvancia y adyuvancia para cáncer de mama receptor de estrógenos-positivo (RE+) y HER2-negativo (HER2-) clínicamente de alto riesgo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ribociclib in combination with endocrine therapy in patients with “estrogen receptor-positive and HER2-negative” breast cancer with high risk of recurrence
    Ribociclib en combinación con terapia endocrina en pacientes con cáncer de mama del tipo “Receptor de estrógenos-positivo y HER2-negativo” con alto riesgo de recidiva
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSOLTI-1911
    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 SponsorSOLTI
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNOVARTIS PHARMA AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOLTI
    B.5.2Functional name of contact pointAREA INVESTIGACION CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressC/ BALMES 89 3-7
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08008
    B.5.4Telephone number+34933436302
    B.5.5Fax number+34932702383
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name KISQALI 200MG
    D. of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRibociclib
    D.3.2Product code LEE011
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeLEE011
    D.3.9.3Other descriptive nameRIBOCICLIB SUCCINATE
    D.3.9.4EV Substance CodeSUB184164
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients with primary operable stage II, grade 2 or 3, Ki67 ≥20%, HR+/HER2- breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.
    Pacientes con cáncer de mama primario operable en estadio II, grado 2 o 3, Ki67 ≥20%, RH+/HER2- para evaluar la seguridad y la eficacia a largo plazo de un tratamiento sin quimioterapia en pacientes biológicamente respondedores a ribociclib y letrozol neoadyuvantes.
    E.1.1.1Medical condition in easily understood language
    Patients (men and women) with “estrogen receptor-positive and HER2-negative” breast cancer, candidates to curative surgery, with high risk of recurrence.
    Pacientes (hombres y mujeres) con cáncer de mama de tipo “Receptor de estrógenos-positivo y HER2-negativo”, candidatos a cirugía curativa y con alto riesgo de recidiva.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 long-term efficacy of neo/adjuvant endocrine therapy + ribociclib in high-risk ER+/HER2-disease and a biological response at surgery (i.e., ROR-low)
    Evaluar la eficacia a largo plazo de la terapia endocrina neo/adyuvante + ribociclib en enfermedad ER+/HER2 de alto riesgo y una respuesta biológica en la cirugía (es decir, ROR bajo).
    E.2.2Secondary objectives of the trial
    1. To evaluate the long-term efficacy of neo/adjuvant endocrine therapy + ribociclib in high-risk ER+/HER2- disease and a biological response at surgery (i.e., ROR-low).
    2. To evaluate the efficacy of ribociclib and endocrine therapy during neoadjuvant treatment.
    3. To evaluate the long-term efficacy of neo/adjuvant endocrine therapy + ribociclib in high-risk ER+/HER2- disease and a lack of biological response at surgery (i.e., ROR-med/high).
    4. To evaluate the safety and tolerability of investigational treatment and their corresponding standard treatment
    1.Evaluar la eficacia a largo plazo de la terapia endocrina neo/adyuvante + ribociclib en la enfermedad RE+/HER2- de alto riesgo y una respuesta biológica en la cirugía (es decir, ROR-bajo).
    2. Evaluar la eficacia del ribociclib y la terapia endocrina durante el tratamiento neoadyuvante.
    3. Evaluar la eficacia a largo plazo de la terapia endocrina neo/adyuvante + ribociclib en la enfermedad RE+/HER2- de alto riesgo y la falta de respuesta biológica en la cirugía (es decir, ROR- medio/alto).
    4. Evaluar la seguridad y tolerabilidad del tratamiento en investigación y su tratamiento estándar correspondiente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Signed Informed Consent Form prior to any study-specific procedure. 2- Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent).3- Male (≥18 years old) or pre-menopausal women (≥40 years old) or post-menopausal women. Premenopausal/male patients will receive LHRH agonists 2 weeks before C1D1 and during treatment. 4- Histologically confirmed invasive breast carcinoma, confirmed by the local pathologist. 5-Breast cancer eligible for primary surgery. 6-Available pre-treatment FFPE core (tru-cut) biopsy evaluable for PAM50 or possibility to obtain one. 7-Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8- Adequate hematological, renal and hepatic function. 9-A male participant must agree to use a contraception as detailed in Appendix 1 of this protocol during the adjuvant chemotherapy period (only non-responder cohort) and for at least 21 days, corresponding to time needed to eliminate any study treatments plus an additional 120 days (a spermatogenesis cycle) after the last dose of chemotherapy and refrain from donating sperm during this period. 10-A female participant is eligible to participate if she is not pregnant, not breastfeeding.
    1- Formulario de consentimiento informado firmado antes de cualquier procedimiento específico del estudio. 2-Nota: Los pacientes candidatos en Francia deben estar afiliados a un Sistema de Seguridad Social (o equivalente). 3-Hombres (≥18 años) o mujeres premenopáusicas (≥40 años) o mujeres posmenopáusicas. 4-Carcinoma de mama invasivo confirmado histológicamente, confirmado por el patólogo local. 5-Cáncer de mama elegible para cirugía primaria. 6- Biopsia de núcleo FFPE (tru-cut) disponible antes del tratamiento evaluable para PAM50 o posibilidad de obtener una. 7-Tener un estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0 a 1. 8-Función hematológica, renal y hepática adecuada. 9-Un varón debe aceptar el uso de un método anticonceptivo como se detalla en el Apéndice 1 de este protocolo durante el período de quimioterapia adyuvante (solo cohorte de no respondedores) y durante al menos 21 días, correspondiente al tiempo necesario para eliminar cualquier tratamiento del estudio más 120 días adicionales (un ciclo de espermatogénesis) después de la última dosis de quimioterapia y abstenerse de la donación de esperma durante este período. 10-Una mujer es elegible si no está embarazada, no está amamantando.
    E.4Principal exclusion criteria
    1. Any prior treatment for primary invasive breast cancer. Letrozole or other drugs used during the preservation of ovarian function are permitted if administered after baseline biopsy. 2. Inoperable breast cancer. 3. Patients with Stage I, III or IV breast cancer are not eligible.
    4. Bilateral invasive breast cancer. 5. Patients who have undergone sentinel lymph node biopsy prior to study treatment. 6. Inability or unwillingness to swallow pills. 7. Malabsorption syndrome or other condition that would interfere with enteric absorption of study drugs. 8. Participation in a prior investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational product, whichever is longer. 9. Patient with a Child-Pugh score B or C. 10. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: a. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening. b. History of documented congestive heart failure (New York Heart Association functional classification III-IV). c. Documented cardiomyopathy.
    d. Patient has a Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO). e. Clinically significant cardiac arrhythmias.
    f. Long QT Syndrome or family history of idiopathic sudden death or congenital long QT syndrome or any of the following:
    g. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia.
    h. QTc >500 msec or conduction abnormality in the previous 12 months. i. On screening 12-lead ECG, any of the following cardiac parameters: bradycardia (resting heart rate <50), tachycardia (resting heart rate >90), PR interval >220 msec, QRS interval >109 msec, or QTcF interval ≥450 msec (using Fridericia’s correction).
    j. Uncontrolled hypertension (Systolic blood pressure >160 mmHg or <90 mmHg and/or diastolic >100 mmHg).
    11. Active infection requiring intravenous (IV) antibiotics.
    12. Prior story of pneumonitis of any cause.
    13. Prior thromboembolic events not attributable to a clear trigger cause. 14. Known human immunodeficiency virus (HIV) infection.
    15. Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may compromise compliance with the protocol, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications. 16. Significant traumatic injury within 3 weeks prior to initiation of study treatment. 17. Major surgical procedure (not including minor procedures such as lymph node biopsy, tumor core biopsy, fine needle aspiration or bilateral oophorectomy) within 3 weeks prior to initiation of study treatment or not fully recovered from any side effects of previous procedures.
    18. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    19. Patients with a history of any malignancy are ineligible except for the following circumstances:
    • Patients with a malignancy history other than invasive breast cancer are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
    • Patients with the following cancers are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancers.20. Estrogen replacement therapy stopped less than 2 weeks before treatment start.
    1.Cualquier tratamiento previo para el cáncer de mama invasivo primario. El letrozol u otros fármacos utilizados durante la preservación de la función ovárica están permitidos si se administran después de la biopsia inicial. 2. Cáncer de mama inoperable. 3. Los pacientes con cáncer de mama en estadio I, III o IV no son elegibles. 4. Cáncer de mama invasivo bilateral. 5. Pacientes que se hayan sometido a una biopsia de ganglio linfático centinela antes del tratamiento del estudio. 6. Incapacidad o falta de voluntad para tragar pastillas. 7. Síndrome de malabsorción u otra afección que pudiera interferir con la absorción entérica de los fármacos del estudio. 8. Participación en un estudio de investigación previo dentro de los 30 días anteriores a la inscripción o dentro de las 5 semividas del producto en investigación, lo que sea más prolongado.
    9. Paciente con una puntuación Child-Pugh B o C.
    10.Paciente con enfermedad cardíaca activa o un historial de disfunción cardíaca que incluye cualquiera de las siguientes situaciones:
    a.Antecedentes de síndromes coronarios agudos (que incluyen infarto de miocardio, angina inestable, injerto de derivación de arteria coronaria, angioplastia coronaria o colocación de stent) o pericarditis sintomática en los 12 meses anteriores a la selección.
    b.Antecedentes de insuficiencia cardíaca congestiva documentada (clasificación funcional III-IV de la New York Heart Association).
    c. Miocardiopatía documentada.
    d. El paciente tiene una fracción de eyección del ventrículo izquierdo (FEVI) <50%, según lo determinado por ventriculografía con radionúclidos (MUGA, por sus siglas en inglés) o ecocardiograma (ECG).e. Arritmias cardíacas clínicamente significativas (p. ej., taquicardia ventricular), bloqueo completo de rama izquierda, bloqueo AV de alto grado (p. ej. bloqueo bifascicular, Mobitz tipo II y bloqueo AV de tercer grado).
    f. Síndrome de QT largo o antecedentes familiares de muerte súbita idiopática o síndrome de QT largo congénito o cualquiera de los siguientes:
    g. Factores de riesgo para Torsades de Pointes (TdP) que incluyen hipopotasemia o hipomagnesemia no corregida, antecedentes de insuficiencia cardíaca o antecedentes de bradicardia clínicamente significativa/sintomática.
    h. QTc > 500 mseg o anomalía de la conducción en los 12 meses anteriores.
    i. En el cribado del ECG de 12 derivaciones, cualquiera de los siguientes parámetros cardíacos: bradicardia (frecuencia cardíaca en reposo <50), taquicardia (frecuencia cardíaca en reposo
    >90), intervalo PR >220 ms, intervalo QRS > 109 ms o QTcF
    intervalo ≥450 mseg (usando la corrección de Fridericia).
    j. Hipertensión no controlada (presión arterial sistólica> 160 mmHg o
    <90 mmHg y/o diastólica> 100 mmHg).
    11. Infección activa que requiere antibióticos por vía intravenosa (IV).
    12. Historia previa de neumonitis por cualquier causa.
    13. Acontecimientos tromboembólicos previos no atribuibles a una causa desencadenante clara.
    14. Infección conocida causada por el virus de la inmunodeficiencia humana (VIH).
    15. Cualquier otra enfermedad, disfunción pulmonar activa o incontrolada, disfunción metabólica, hallazgo del examen físico o hallazgo de laboratorio clínico que dé una sospecha razonable de una enfermedad o afección que contraindique el uso de un fármaco en investigación, que pueda comprometer el cumplimiento del protocolo, que pueda afectar la interpretación de los resultados, o que ponga a los pacientes en alto riesgo de complicaciones derivados del tratamiento.
    16. Lesión traumática significativa en las 3 semanas previas al inicio del tratamiento del estudio.
    17. Procedimiento quirúrgico mayor (sin incluir procedimientos menores como biopsia de ganglio linfático, biopsia del núcleo del tumor, aspiración con aguja fina u ooforectomía bilateral) dentro de las 3 semanas anteriores al inicio del tratamiento del estudio o no recuperado por completo de los efectos secundarios de intervenciones anteriores.
    18. Cualquier afección psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo del estudio y el cronograma de seguimiento.
    19. Los pacientes con antecedentes de alguna neoplasia maligna no son elegibles excepto en las siguientes circunstancias:
    •Los pacientes con antecedentes de malignidad diferente al cáncer de mama invasivo son elegibles si han estado libres de la enfermedad durante al menos 5 años y el investigador considera que tienen un riesgo bajo de recidiva de esa malignidad.
    •Los pacientes con los siguientes tipos de cáncer son elegibles, incluso si se han diagnosticado y tratado en los últimos 5 años: carcinoma ductal in situ de mama, cáncer de cuello uterino in situ y cánceres de piel no melanomatosos, no metastásicos.20. Terapia de sustitución de estrógenos interrumpida menos de 2 semanas antes del inicio del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Distant metastasis-free survival (DMFS) DMFS is defined as the time from date of surgery to date of first event of distant metastatic recurrence or death (any cause).
    Supervivencia libre de enfermedad (metástasis) a distancia (SLED). La SLED se define como el tiempo desde la fecha de la cirugía hasta la fecha del primer evento de recidiva metastásica a distancia o muerte (por cualquier causa).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from date of surgery to date of first event of distant metastatic recurrence or death (any cause).
    El tiempo desde la fecha de la cirugía hasta la fecha del primer evento de recidiva metastásica a distancia o muerte (por cualquier causa).
    E.5.2Secondary end point(s)
    1.1 Invasive disease-free survival (IDFS): iDFS is defined as the time from surgery until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive disease, a distant disease recurrence, contralateral invasive breast cancer, second primary or death from any cause.
    2.1 pCR in the breast and axillary lymph nodes (pCRBL) after completion of study treatment, defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery, irrespective of in situ carcinoma in the breast.
    2.2 Rate of RCB0/1 after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per local assessment.
    3.1 Estimation of DMFS in ROR-med/high group.
    4.1. Incidence, duration and severity of Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4.03, including dose reductions, delays and treatment discontinuations.
    1.1 Supervivencia libre de enfermedad invasiva (SLEI): SLEI se define como el tiempo desde la cirugía hasta la fecha de la primera aparición de uno de los siguientes eventos: recidiva del tumor de mama invasivo ipsolateral, recidiva de la enfermedad invasiva locorregional ipsolateral, una recidiva de la enfermedad a distancia, cáncer de mama invasivo contralateral, segundo primario o muerte por cualquier causa.
    2.1 RCp en la mama y los ganglios linfáticos axilares (RCpBL) después de completar el tratamiento del estudio, definido como la ausencia completa de carcinoma invasivo en la mama y los ganglios linfáticos axilares en el examen histológico en el momento de la cirugía definitiva, independientemente del carcinoma in situ en la mama.
    2.2 Tasa de RCB0/1 después del tratamiento neoadyuvante, según los criterios del MD Anderson Cancer Center y evaluado localmente.
    3.1 Estimación de SLED en el grupo ROR-medio/alto.
    4.1. Incidencia, duración y gravedad de los acontecimientos adversos (AA) evaluados por la Terminología común para la clasificación de acontecimientos adversos del NCI (CTCAE) versión 4.03, incluidas las reducciones de dosis, los retrasos y las interrupciones del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) The time from surgery until the date of the first occurrence of invasive disease (defined at the protocol)
    2) At the time of definitive surgery
    3) The time from date of surgery to date of first event of distant metastatic recurrence or death (any cause).
    4) From the signature of the IC until the 30-day post-ribociclib safety visit (approximately after 3 years from patient inclusion)
    1) El tiempo desde la fecha de la cirugía hasta la fecha del primer evento de enfermedad invasiva (definido en el protocolo).
    2) En el momento de la cirugía definitiva
    3) El tiempo desde la fecha de la cirugía hasta la fecha del primer evento de recidiva metastásica a distancia o muerte (por cualquier causa).
    4) Desde la firma del CI hasta la visita de seguridad a los 30 días post-discontinuación del ribociclib (aproximadamente 3 años tras la inclusión del paciente).
    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 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. 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Las Patient Last Visit (LPLV)
    Ultimo paciente Ultima visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    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 state175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 530
    F.4.2.2In the whole clinical trial 530
    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 patient will follow the treatment indicated by the doctor as standard of care
    El paciente seguirá el tratamiento que le indique su medico por practica clinica habitual
    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 Decision2022-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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