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    Summary
    EudraCT Number:2021-002027-38
    Sponsor's Protocol Code Number:SOLTI-2101
    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:2021-11-18
    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 number2021-002027-38
    A.3Full title of the trial
    A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trial
    Estudio de fase III, multicéntrico y abierto de ribociclib en comparación con palbociclib en pacientes con cáncer de mama avanzado con receptores hormonales positivos/HER2-negativo/HER2-Enriquecido - ensayo HARMONIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study of ribociclib and palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trial
    Estudio para comparar ribociclib y palbociclib en pacientes con cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido - ensayo HARMONIA
    A.3.2Name or abbreviated title of the trial where available
    HARMONIA
    HARMONIA
    A.4.1Sponsor's protocol code numberSOLTI-2101
    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.1.3.4CountrySpain
    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.4.2CountrySwitzerland
    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 DE INVESTIGACION CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressBalmes, 89 3-7
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number34933436302
    B.5.6E-mailregsolti@gruposolti.org
    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.2.1.1.1Trade name KISQALI 200 MG
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.1Product 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 INNRibociclib
    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.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 Yes
    D.2.1.1.1Trade name IBRANCE 75 MG
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 namePalbociclib
    D.3.2Product code PD-0332991
    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 INNPalbociclib
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 3
    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.2.1.1.1Trade name IBRANCE 100 MG
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 namePalbociclib
    D.3.2Product code PD-0332991
    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 INNPalbociclib
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.2.1.1.1Trade name IBRANCE 125 MG
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 namePalbociclib
    D.3.2Product code PD-0332991
    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 INNPalbociclib
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer
    Pacientes con cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido (HER2-E)
    E.1.1.1Medical condition in easily understood language
    Advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer
    Cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido (HER2-E)
    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 compare PFS of ribociclib plus endocrine therapy over palbociclib plus endocrine therapy with respect to PFS in patients with advanced hormone receptor-positive, HER2-negative and HER2-E breast cancer.
    Comparar ribociclib más tratamiento endocrino con palbociclib más tratamiento endocrino en cuanto a la SSP en pacientes con cáncer de mama avanzado con receptores hormonales positivos, HER2 negativo y HER2-E.
    E.2.2Secondary objectives of the trial
    •To compare the two treatment arms with respect to Progression on next-line therapy (PFS2) in the HER2-E cohort
    •To compare the two treatment arms with respect to overall survival in the HER2-E cohort
    •To evaluate the two treatment arms with respect to overall response rate (ORR) and clinical benefit rate (CBR) in the HER2-E cohort.
    •To describe time to response and duration of response in each treatment arm in the HER2-E cohort.
    •To evaluate the safety and tolerability of ribociclib and palbociclib in combination with endocrine therapy in the HER2-E cohort
    •To evaluate patient reported outcomes for health-related quality of life in the two treatment arms of the HER2-E cohort.
    •Comparar los dos grupos de tratamiento en cuanto a la SSP2 en la cohorte con HER2-E.
    •Comparar los dos grupos de tratamiento en cuanto a la supervivencia global en la cohorte con HER2-E.
    •Evaluar los dos grupos de tratamiento en cuanto a la tasa de respuesta global (TRG) y la tasa de beneficio clínico (TBC) en pacientes con HER2-E, definiéndose la TBC como el porcentaje de pacientes con RC o RP conforme a los criterios RECIST o EE de 24 semanas o más de duración.
    •Describir el tiempo transcurrido hasta la respuesta y la duración de la respuesta en cada grupo de tratamiento.
    •Evaluar la seguridad y la tolerabilidad de ribociclib y palbociclib en combinación con tratamiento endocrino en la cohorte con HER2-E.
    •Evaluar resultados comunicados por los pacientes en cuanto a calidad de vida relacionada con la salud en los dos grupos de tratamiento de la cohorte con HER2-E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male/female patients ≥18 years of age
    2. HR-positive and HER2-negative breast cancer by local testing
    3. ECOG performance status of 0 to 1.
    4. Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
    5. Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period.
    6. HER2-E or Basal-like subtype as per central PAM50 analysis.
    7. Measurable disease or non-measurable (but evaluable), as defined by RECIST v1.1.
    8. Adequate hematologic and end-organ function
    9. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
    10. Women of childbearing potential must have confirmed negative serum pregnancy test.
    11. Women of CBP must be willing to use highly effective methods of contraception.
    12. Postmenopausal OR Pre/perimenopausal status as defined in protocol
    13. Patients must have the ability to swallow oral medication.
    14. Patient must have a 6-lead or 12-lead ECG at screening
    1. Pacientes masculinos/femeninos ≥18 años de edad
    2. Cáncer de mama HR positivo y HER2 negativo evaluado localmente
    3. Estado de rendimiento ECOG de 0 a 1.
    4. La paciente tiene cáncer de mama avanzado (recurrente loco regionalmente o no metastásica, no susceptible de terapia curativa).
    5. Disponibilidad de bloque tumoral FFPE para el análisis de biomarcadores, obtenido durante el período metastásico.
    6. Subtipo HER2-E o Basal-Like según el análisis central PAM50.
    7. Enfermedad medible o no medible (pero evaluable), según lo definido por RECIST v1.1.
    8. Función hematológica y de órganos finales adecuada
    9. El paciente debe estar dispuesto y ser capaz de cumplir con las visitas programadas, los planes de tratamiento, las pruebas de laboratorio y otros procedimientos de ensayo.
    10. Las mujeres en edad fértil deben tener una prueba de embarazo sérica negativa confirmada.
    11. Las mujeres de CBP deben estar dispuestas a usar métodos anticonceptivos altamente efectivos.
    12. Estado posmenopáusica O pre/perimenopáusica según se define en el protocolo
    13. Los pacientes deben tener la capacidad de tragar medicamentos orales.
    14. ECG de 12lead o 6 lead
    E.4Principal exclusion criteria
    1. Prior therapy with any CDK4/6 inhibitors.
    2. Patient has received prior treatment with chemotherapy for advanced / metastatic breast cancer (neoadjuvant/ adjuvant chemotherapy for early breast cancer is allowed).
    3. Patient has received extended-field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to enrollment and has not recovered to grade 1 or better from related side effects of such therapy. Patients in whom ≥ 25% of the bone marrow has been previously irradiated are also excluded[60].
    4. Any ongoing acute toxic effects of prior anti-cancer therapy or major surgical procedures to NCI CTCAE version 4.03 Grade ≤ 1 at day of inclusion.
    5. Uncontrolled pleural effusion, pericardial effusion, or ascites.
    6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    7. Known active central nervous system metastases and/or carcinomatous meningitis.
    8. Known history of Human Immunodeficiency Virus (HIV).
    9. Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    10. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
    11. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol or limit life expectancy to ≤6 months.
    12. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s)
    13. Pregnant or breast-feeding women or women who plan to become pregnant or breast-feed during the trial.
    14. Not able to understand and to comply with study instructions and requirements according to investigator criteria.

    For HER2-E cohort only:
    15. Patient with a known hypersensitivity to any of the excipients of ribociclib, palbociclib and/or endocrine therapy
    16. Patient is currently receiving any protocol-prohibited substances within 7 days before randomization
    17. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment, or has not fully recovered from side effects of such treatment.
    18. Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
    For Basal-like cohort only:
    19. History of hypersensitivity reactions to paclitaxel or other drugs formulated in the same solvent as paclitaxel (polyoxyethylated castor oil)
    1. Terapia previa con cualquier inhibidor de CDK4/6.
    2. La paciente ha recibido tratamiento previo con quimioterapia para el cáncer de mama avanzado / metastásico (se permite la quimioterapia neoadyuvante / adyuvante para el cáncer de mama temprano).
    3. El paciente ha recibido radioterapia de campo extendido ≤ 4 semanas o radioterapia de campo limitada ≤ 2 semanas antes de la inscripción y no se ha recuperado al grado 1 o mejor de los efectos secundarios relacionados de dicha terapia. También se excluyen los pacientes en los que ≥ el 25% de la médula ósea ha sido irradiada previamente[60].
    4. Cualquier efecto tóxico agudo en curso de la terapia previa contra el cáncer o procedimientos quirúrgicos mayores al NCI CTCAE versión 4.03 Grado ≤ 1 al día de la inclusión.
    5. Derrame pleural no controlado, derrame pericárdico o ascitis.
    6. Tiene una neoplasia maligna adicional conocida que está progresando o ha requerido tratamiento activo en los últimos 3 años.
    7. Metástasis activas conocidas del sistema nervioso central y/o meningitis carcinomatosa.
    8. Antecedentes conocidos del Virus de la Inmunodeficiencia Humana (VIH).
    9. El paciente tiene una infección conocida por el virus activo de la hepatitis B (VHB) o el virus de la hepatitis C (VHC)
    10. Enfermedad cardíaca no controlada clínicamente significativa y/o anomalía de la repolarización cardíaca
    11. El paciente tiene cualquier otra condición médica concurrente grave y / o no controlada que, a juicio del Investigador, causaría riesgos de seguridad inaceptables, contraindicaría la participación del paciente en el ensayo clínico o comprometería el cumplimiento del protocolo o limitaría la esperanza de vida a ≤6 meses.
    12. Participación en otros estudios que involucren fármaco(s) en investigación dentro de los 30 días anteriores a la asignación al azar o dentro de las 5 vidas medias de los fármacos en investigación
    13. Mujeres embarazadas o en período de lactancia o mujeres que planean quedar embarazadas o amamantar durante el ensayo.
    14. No es capaz de comprender y cumplir con las instrucciones y requisitos del estudio de acuerdo con los criterios del investigador.

    Solo para la cohorte HER2-E:
    15. Paciente con hipersensibilidad conocida a alguno de los excipientes de ribociclib, palbociclib y/o terapia endocrina
    16. El paciente está recibiendo actualmente cualquier sustancia prohibida por protocolo dentro de los 7 días anteriores a la aleatorización
    17. El paciente está recibiendo actualmente o ha recibido corticosteroides sistémicos ≤ 2 semanas antes de comenzar el tratamiento del ensayo, o no se ha recuperado completamente de los efectos secundarios de dicho tratamiento.
    18. El paciente tiene deterioro de la función gastrointestinal o enfermedad gastrointestinal que puede alterar significativamente la absorción oral de los tratamientos de ensayo
    Solo para la cohorte Basal-Like:
    19. Antecedentes de reacciones de hipersensibilidad al paclitaxel u otros fármacos formulados en el mismo disolvente que el paclitaxel (aceite de ricino polioxietilado)
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival using RECIST 1.1 criteria, as assessed by local radiologists/investigators
    SSP conforme a los criterios RECIST 1.1, evaluada por radiólogos/investigadores locales
    E.5.1.1Timepoint(s) of evaluation of this end point
    Image testing will be done mandatory, every 8 weeks (+/- 7 days) for the first 12 months, then every 12 weeks (+/- 7 days)
    Las pruebas de imagen se realizarán de forma obligatoria, cada 8 semanas (+/- 7 días) durante los primeros 12 meses, luego cada 12 semanas (+/- 7 días
    E.5.2Secondary end point(s)
    PFS2, defined as the time from randomization to first documented progression on next-line therapy or death, whichever occurs first
    OS
    Overall response and clinical benefit as defined by RECIST 1.1.
    Time to response and duration of response per RECIST 1.1
    Occurrence /severity of AEs, laboratory abnormalities, discontinuation rates, dose reductions/interruptions

    Time to 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30
    Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30
    Change from baseline in the fatigue scale score of the FACT-G score of FACIT Fatigue Scale (Version 4)
    SSP2, definida como el tiempo transcurrido entre la aleatorización y la primera progresión documentada con la siguiente línea de tratamiento o la muerte, lo que ocurra antes.
    SG.
    Respuesta global y beneficio clínico según se definen en los criterios RECIST 1.1.
    Tiempo transcurrido hasta la respuesta y duración de la respuesta conforme a los criterios RECIST 1.1.
    Incidencia e intensidad de AA, anomalías analíticas, tasas de suspensión del tratamiento, reducciones de la dosis e interrupciones de la administración.

    Tiempo transcurrido hasta un deterioro del 10% de la puntuación en la escala de estado general de salud/calidad de vida del cuestionario QLQ-C30 de la EORTC.
    Variación con respecto al momento basal de la puntuación en la escala de estado general de salud/calidad de vida del cuestionario QLQ-C30 de la EORTC.
    Variación con respecto al momento basal de la puntuación en la escala de fatiga de la puntuación FACT-G de la escala FACIT-Fatiga (versión 4).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Follow up for PFS2 and OS will be every 6 months
    2.Image testing will be done mandatory, every 8 weeks (+/- 7 days) for the first 12 months, then every 12 weeks (+/- 7 days)
    3.Safety (incidence of AEs) will be monitored continuously, until 30 days after discontinuation
    4.Patient reported outcomes will be done every two cycles for the first 12 months, then every three cycles
    1.El seguimiento de SSP2 y SG será cada 6 meses
    2.Las pruebas de imagen se realizarán de forma obligatoria, cada 8 semanas (+/- 7 días) durante los primeros 12 meses, luego cada 12 semanas (+/- 7 días)
    3.La seguridad (incidencia de eventos adversos) se hará continuamente, hasta 30 días después de la interrupción
    4.Los cuestionarios informados por el paciente se realizarán cada dos ciclos durante los primeros 12 meses, luego cada tres ciclos
    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 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.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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    United States
    Portugal
    Spain
    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
    Last Subject Last Visit (LSLV)
    Ultimo Paciente Ultima Visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients can give consent through impartial witness and/or legal representative
    Los pacientes pueden dar su consentimiento a través de un testigo imparcial y / o representante legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state266
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 296
    F.4.2.2In the whole clinical trial 516
    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)
    Treatment as Standard of Care
    Tratamiento según 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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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