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    Summary
    EudraCT Number:2017-003466-28
    Sponsor's Protocol Code Number:DS8201-A-J203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-07
    Trial results View 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 number2017-003466-28
    A.3Full title of the trial
    A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
    Estudio de fase 2, multicéntrico, abierto de DS-8201a en sujetos con cáncer colorrectal avanzado que expresa HER2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
    Estudio de fase 2, multicéntrico, abierto de DS-8201a en sujetos con cáncer colorrectal avanzado que expresa HER2
    A.4.1Sponsor's protocol code numberDS8201-A-J203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03384940
    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 Mount 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
    B.5.6E-maileu_cta@dsi.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 nameDS-8201a
    D.3.4Pharmaceutical form Powder 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancer
    Cáncer colorrectal avanzado que expresa el receptor 2 del factor de crecimiento epidérmico humano (HER2)
    E.1.1.1Medical condition in easily understood language
    Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancer
    Cáncer colorrectal avanzado que expresa el receptor 2 del factor de crecimiento epidérmico humano (HER2)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010029
    E.1.2Term Colorectal cancer NOS
    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 determine the objective response rate (ORR) of DS-8201a in HER2-expressing advanced metastatic colorectal cancer patients
    • Determinar la tasa de respuesta objetiva (TRO) de DS-8201a en pacientes con cáncer colorrectal con metástasis avanzado que expresa HER2.
    E.2.2Secondary objectives of the trial
    •To evaluate duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). ORR assessed by the investigator is also evaluated.
    •To evaluate the safety of DS-8201a
    •To determine the pharmacokinetics (PK) of DS-8201a
    • Evaluar la duración de la respuesta (DR), la tasa de control de la enfermedad (TCE), la supervivencia libre de progresión (SLP) y la supervivencia global (SG). También se analiza la TRO evaluada por el investigador.
    • Evaluar la seguridad de DS-8201a
    • Determinar la farmacocinética (FC) de DS-8201a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Has pathologically documented unresectable, recurrent, or metastatic
    colorectal adenocarcinoma (until sponsor's notification to the study
    sites, subject must be a RAS/BRAF wild-type cancer)
    - Has received at least 2 prior regimens of standard treatment
    - Has measurable disease assessed by the investigator based on RECIST
    version 1.1.
    - Has an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 to 1
    - Tiene un adenocarcinoma colorrectal irresecable, recurrente o metastático documentado mediante patología. Hasta que el promotor no notifique a los centros del estudio, el sujeto debe presentar cáncer RAS/ homólogo B1 del oncogén del sarcoma viral murino v-raf (BRAF).
    - Ha recibido al menos 2 pautas anteriores de tratamiento de referencia.
    - Tiene lesión cuantificable evaluada por el investigador según los Criterios de evaluación de la respuesta en tumores sólidos RECIST versión 1.1.
    - Presenta un estado funcional del Grupo Oncológico Cooperativo de la Costa Este de los EE. UU. (ECOG PS) de 0 a 1.
    E.4Principal exclusion criteria
    - Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
    - Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
    - Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
    - Tiene historia clínica de infarto de miocardio en los 6 meses anteriores a la inclusión, insuficiencia cardíaca congestiva sintomática
    - Tiene antecedentes de enfermedad pulmonar intersticial/neumonitis (no infecciosa) que ha requerido tratamiento con esteroides, presenta enfermedad pulmonar intersticial/neumonitis actualmente o no puede descartarse una sospecha de enfermedad pulmonar intersticial/neumonitis con las imágenes obtenidas en la selección.
    - Presenta compresión medular o metástasis en el sistema nervioso central clínicamente activa, que se define como no tratada y sintomática, o que requiere tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) per imaging assessment - Percentage of participants with objective response per independent central imaging
    facility review based on Response Evaluation Criteria In Solid Tumors
    (RECIST) version 1.1
    Tasa de respuesta objetiva (TRO) evaluada mediante revisión por la imagen_Porcentaje de participantes con respuesta objetiva por parte del centro de estudios por la imagen central e independiente en función de RECIST versión 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 weeks
    cada 6 semanas
    E.5.2Secondary end point(s)
    ・Progression-free survival
    ・Overall survival
    ・Duration of response
    ・Disease control rate (DCR)
    ・ORR assessed by the investigator based on RECIST version 1.1
    The following apply to categories; DS-8201a, total anti-HER2 antibody,
    and MAAA-1181a
    ・Maximum serum/plasma concentration (Cmax)
    ・ Time to Cmax (Tmax)
    ・Area under the concentration-time curve (AUC)
    ・AUC from the time of dosing until day 21 (AUC0-21d)
    - Supervivencia libre de progresión
    - Supervivencia global
    - Duración de la respuesta
    - Tasa de control de la enfermedad (TCE)
    - TRO evaluada por el investigador en función de RECIST versión 1.1.
    Los siguientes aplican a las categorías DS-8201a, anticuerpo anti-HER2 total y MAAA-1181a:
    - Máxima concentración suero/plasma Cmáx
    - Tiempo a la Cmáx (Tmáx)
    - Área bajo la curva concentración –tiempo (ABC)
    - ABC0 desde el momento de la dosis hasta el dia 21 (AUC0-21d)
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 6 weeks for efficacy, OS for until death or last contact with subject
    cada 6 semanas para la eficacia, SG hasta defunción o ultimo contacto con el 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Italy
    Japan
    Spain
    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
    End of OS follow-up
    Fin del seguimiento de la SG
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 90
    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 Decision2018-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-10
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