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    EudraCT Number:2019-001512-34
    Sponsor's Protocol Code Number:DS8201-A-U205
    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:2019-07-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-001512-34
    A.3Full title of the trial
    Estudio en fase II abierto de un único grupo de trastuzumab deruxtecán (DS-8201a) en sujetos con adenocarcinoma gástrico o de la unión gastroesofágica (UGE) positivo para HER2, no resecable o metastásico que han progresado durante o después de una pauta que contenía trastuzumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DS-8201a in HER2-positive Gastric Cancer that cannot be surgically removed or has spread
    (DS-8201a) en sujetos con adenocarcinoma gástrico que no se puede extirpar quirúrgicamente o que se ha diseminado
    A.4.1Sponsor's protocol code numberDS8201-A-U205
    A.5.4Other Identifiers
    Name:IND NumberNumber:136179
    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 SponsorDaiichi Sankyo Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDAIICHI SANKYO INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Inc.
    B.5.2Functional name of contact pointNot applicable
    B.5.3 Address:
    B.5.3.1Street Address211 Mt Airy Road
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908992 6400
    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 nameDS-8201a
    D.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Lyophilisate 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 INNTrastuzumab deruxtecan
    D.3.9.2Current sponsor codeDS-8201A
    D.3.9.3Other descriptive nameAnti-HER2 antibody-drug conjugate
    D.3.9.4EV Substance CodeSUB188940
    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 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. 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 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.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
    Unresectable or metastatic gastric or gastro-esophageal junction (GEJ)
    adenocarcinoma that has progressed on or after a trastuzumab-containing
    Adenocarcinoma gástrico o de la unión gastroesofágica (UGE) no resecable o metastásico que han progresado durante o después de una pauta que contenía trastuzumab
    E.1.1.1Medical condition in easily understood language
    Adenocarcinoma gástrico o de la unión gastroesofágica (UGE ) positivo para HER2, no resecable o metastásico
    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 LLT
    E.1.2Classification code 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of Trastuzumab Deruxtecan (DS-8201a) based on objective response rate (ORR) by independent central review based on Response Evaluation Criteria in Solid Tumors (RECIST), version (v)1.1
    Investigar la eficacia de trastuzumab deruxtecan en base a la tasa de respuesta objetiva (TRO) mediante una revisión central independiente según la versión (v)1.1 de los Criterios de evaluación de la respuesta en tumores sólidos (RECIST)
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of Trastuzumab Deruxtecan on progression-free survival (PFS), based on independent central review using RECIST v1.1.

    Other secondary objectives:
    - To further evaluate the efficacy of Trastuzumab Deruxtecan using the endpoint of overall survival (OS)

    - To further evaluate the efficacy of Trastuzumab Deruxtecan using RECIST v1.1 for endpoints of PFS and ORR based on Investigator assessment, and on duration of response (DoR) based on independent central review and Investigator assessment

    - To determine the pharmacokinetics (PK) of Trastuzumab Deruxtecan in serum

    - To further evaluate the safety of Trastuzumab Deruxtecan based on treatment-emergent adverse events (TEAEs) and anti-drug antibodies (ADAs)

    - To evaluate Health Economics and Outcomes Research (HEOR) endpoints based on patient-reported outcomes (PROs)
    •Evaluar la eficacia de trastuzumab deruxtecan en la supervivencia sin progresión (SSP), en base a una revisión central independiente usando los criterios RECIST v1.1
    •Evaluar más la eficacia de trastuzumab deruxtecán usando el criterio de valoración de supervivencia general (SG)
    •Evaluar aún más la eficacia de trastuzumab deruxtecán usando los criterios RECIST v1.1 para criterios de valoración de SSP y TRO según la evaluación del investigador, y en la duración de la respuesta (DR) en base a revisión central independiente y la evaluación del investigador
    •Determinar la farmacocinética (FC) de trastuzumab deruxtecán en suero
    • Evaluar aún más la seguridad de trastuzumab deruxtecán en base a acontecimientos adversos surgidos durante el tratamiento (AAST) y anticuerpos antifármaco (AAF)
    • Evaluar los criterios de valoración de economía sanitaria e investigación de resultados (Health Economics and Outcomes Research, HEOR) en base a los resultados notificados por el paciente (RNP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:

    - Men or women ≥18 years old (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years old.)
    - Has pathologically documented gastric or GEJ cancer that is:
    - Unresectable or metastatic
    - Centrally confirmed HER2-positive disease (immunohistochemistry [IHC]3+, IHC2+/in-situ hybridization [ISH]+) as determined according to American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines based on a new tissue sample obtained after progression on or after a trastuzumabcontaining regimen. If a tissue sample was already collected after discontinuation of first-line treatment with a trastuzumab-containing regimen, it is acceptable to consider this a new biopsy for the purpose of this study.

    - Experienced disease progression during or after first-line therapy with a trastuzumab-containing regimen (brand or approved biosimilar). Note: Prior adjuvant therapy with a trastuzumab-containing regimen can be counted as a line of therapy if the subject progressed on or within 6 months of completing adjuvant therapy.

    - Has at least 1 measurable lesion per RECIST v1.1 as confirmed by independent central review.

    - Has left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment per echocardiogram
    (ECHO)/multigated acquisition (MUGA) scan.

    - Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study drug.

    - Adequate renal function, defined as creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation.

    - Adequate hepatic function, defined as total bilirubin ≤1.5 × upper limit of normal (ULN); serum albumin ≥2.8 g/dL; aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × ULN in the absence of liver metastases or ≤5 × ULN in the presence of liver metastases.
    • Hombres o mujeres ≥18 años de edad (siga las disposiciones reglamentarias locales si la edad legal de consentimiento para la participación en el estudio es de >18 años)
    • Tener cáncer gástrico o de la UGE documentado por anatomía patológica que sea:
    No resecable o metastásico
    Enfermedad positiva para HER2 centralmente confirmada (inmunohistoquímica [IHQ]3+, IHQ2+/hibridación in situ [ISH]+) determinada de acuerdo con las directrices de la Sociedad Estadounidense de Oncología Clínica/Colegio de Anatomopatólogos Estadounidenses (American Society of Clinical Oncology – College of American Pathologists, ASCO-CAP) en base a una muestra de tejido nueva obtenida tras la progresión durante o después de una pauta que contenga trastuzumab. Si ya se recogió una muestra de tejido después de la interrupción del tratamiento de primera línea con una pauta que contenía trastuzumab, es aceptable considerarla como una nueva biopsia para el propósito de este estudio.
    • Haber sufrido progresión de la enfermedad durante o después del tratamiento de primera línea con una pauta que contuviera trastuzumab (de marca comercial o biosimilar aprobado). Nota: el tratamiento adyuvante previo con una pauta que contuviera trastuzumab se puede contar como una línea de tratamiento si el paciente progresó durante o en el plazo de 6 meses desde la finalización del tratamiento adyuvante.
    • Tener al menos 1 lesión medible de acuerdo con los criterios RECIST v1.1 según lo confirmado por una revisión central independiente.
    • Tener una fracción de eyección ventricular izquierda (FEVI) ≥50 % en los 28 días anteriores a la inscripción mediante exploración por ecocardiograma (ECO)/ventriculografía isotópica (MUGA).
    • Los sujetos de sexo masculino y femenino en edad fértil/con capacidad de concebir deben aceptar usar un método anticonceptivo altamente eficaz o evitar las relaciones sexuales durante y hasta la finalización del estudio y durante al menos 4,5 meses después de la última dosis del fármaco del estudio.
    • Función renal adecuada, definida como un aclaramiento de creatinina ≥30 ml/min, calculado con la ecuación de Cockcroft-Gault.
    • Función hepática adecuada, definida como bilirrubina total ≤1,5 × límite superior de la normalidad (LSN); albúmina sérica ≥2,8 g/dl; aspartato transaminasa (AST)/alanina transaminasa (ALT) ≤3 × LSN en ausencia de metástasis hepáticas o ≤5 × LSN en presencia de metástasis hepáticas.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:

    - Use of anticancer therapy after first-line treatment with a trastuzumab-containing regimen.

    - Uncontrolled or significant cardiovascular disease, including any of the following:
    - History of myocardial infarction (MI) within 6 months before enrollment
    - History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
    - Troponin levels consistent with MI as defined according to the manufacturer within 28 days prior to enrollment
    - History of unstable angina or serious cardiac arrhythmia requiring treatment
    - Corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based on Screening triplicate 12-lead electrocardiogram (ECG)

    - History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required corticosteroid therapy or has current ILD/pneumonitis or is suspected to have such diseases by imaging during Screening.

    - Clinically significant corneal disease, in the opinion of the Investigator.

    - Pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to or during Screening.)

    - Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
    - Subjects with clinically inactive brain metastases may be included in the study.
    - Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (1 week for stereotactic radiotherapy).
    •Uso de tratamientos antineoplásicos después del tratamiento de primera línea con una pauta que contuviera trastuzumab.
    •Enfermedad cardiovascular no controlada o significativa, incluidas cualquiera de las siguientes:
    Antecedentes de infarto de miocardio (IM) en los 6 meses anteriores a la inscripción.
    Antecedentes de insuficiencia cardíaca congestiva sintomática (clases II a IV según la Asociación Neoyorquina de Cardiología [New York Heart Association]).
    Niveles de troponina coherentes con IM según la definición del fabricante en los 28 días anteriores a la inscripción.
    Antecedentes de angina de pecho inestable o arritmia cardíaca grave que requiere tratamiento.
    Prolongación del intervalo QT corregido (QTc) a >470 ms (mujeres) o >450 ms (hombres) en base al electrocardiograma (ECG) de 12 derivaciones por triplicado de la selección.
    •Antecedentes de enfermedad pulmonar intersticial (EPI) (no infecciosa) o neumonitis que requirió tratamiento con corticoesteroides o presencia actual de EPI/neumonitis, o sospecha de la presencia de estas enfermedades según la exploración por imágenes durante la selección.
    •Enfermedad corneal clínicamente significativa, en opinión del investigador.
    •Derrame pleural, ascitis o derrame pericárdico que requiere drenaje, derivación peritoneal, o tratamiento de reperfusión acelular y concentrado de la ascitis (CART). (El drenaje y el CART no están permitidos en las 2 semanas previas a o durante la selección).
    •Compresión de la médula espinal o metástasis en el sistema nervioso central clínicamente activas, definidas como no tratadas y sintomáticas o que requieran tratamiento con corticoesteroides o anticonvulsivos para controlar los síntomas asociados.
    Los sujetos con metástasis cerebrales clínicamente inactivas pueden ser incluidos en el estudio.
    Los sujetos con metástasis cerebrales tratadas que ya no son sintomáticas y que no requieren tratamiento con corticoesteroides o anticonvulsivos pueden ser incluidos en el estudio si se han recuperado del efecto tóxico agudo de la radioterapia. Debe haber transcurrido un mínimo de 2 semanas entre el final de la radioterapia cerebral total y la inscripción en el estudio (1 semana para la radioterapia estereotáctica)
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed ORR (objective response rate) based on independent central review
    TRO (tasa de respuesta objetiva) confirmada, en base a una revisión central independiente
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of ORR will be performed for all enrolled subjects at the 18-week tumor assessment.
    Analisis de la TRO se realizará para todos los sujetos inscritos en la evaluación del tumor de 18 semanas
    E.5.2Secondary end point(s)
    Progression-Free Survival (PFS) , based on independent central review using RECIST v1.1.

    Other Secondary Endpoints:
    - PFS, based on Investigator assessment
    - Objective response rate (ORR), based on Investigator assessment
    - Overall survival (OS)
    - Duration of Response (DoR), based on independent central review and Investigator assessment
    Supervivencia sin progresión (SSP), basada en una revisión central independiente mediante RECIST v1.1.

    • SSP, en base a la evaluación del investigador
    • TRO, en base a la evaluación del investigador
    • SG (supervivencia general)
    •DR, en base a una revisión central independiente y la evaluación del investigador
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study. Based on independent central review
    A lo largo del estudio. Basado en revisión central independiente
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study will occur when all enrolled subjects have either completed their last scheduled visit or died or withdrawn from study participation, which is anticipated to occur approximately 12 months after the last subject is enrolled
    El final del estudio se producirá cuando todos los sujetos reclutados hayan completado su última visita programada o hayan fallecido o hayan abandonado la participación en el estudio, lo que se prevé que ocurra aproximadamente 12 meses después de que se reclute el último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 72
    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)
    See protocol
    Ver protocolo
    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 Decision2019-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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