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    Summary
    EudraCT Number:2016-004986-18
    Sponsor's Protocol Code Number:DS8201-A-U201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-004986-18
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated with T-DM1.
    Studio multicentrico, in aperto, di Fase 2 su DS-8201a, un coniugato anticorpo anti-Her2/farmaco (ADC) per soggetti affetti da carcinoma mammario HER2-positivo, non resecabile e/o metastatico trattati precedentemente con T-DM1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study of DS-8201a for HER2-Positive breast cancer that has either spread and/or cannot be treated with surgery and is resistant or non-responsive to T-DM1 treatment.
    Uno studio di Fase 2 di DS-8201a per il cancro al seno HER2-Positivo che si ¿ diffuso e / o non pu¿ essere trattato con interventi chirurgici ed ¿ resistente o non rispondente al trattamento T-DM1.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    n/a
    A.4.1Sponsor's protocol code numberDS8201-A-U201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03248492
    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 pointNA
    B.5.3 Address:
    B.5.3.1Street Address211 Mt Airy Rd
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920-2311
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019089926400
    B.5.5Fax number0000000
    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.3.2Product code DS-8201a
    D.3.4Pharmaceutical form 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 codeMAAA-1162a
    D.3.9.4EV Substance CodeSUB188940
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 7
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 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 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 codeMAAA-1162a
    D.3.9.4EV Substance CodeSUB188940
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 7
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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/metastatic breast cancer with HER2 positive expression
    carcinoma mammario HER2-positivo, non resecabile e/o metastatico
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Carcinoma mammario
    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 10027475
    E.1.2Term Metastatic breast cancer
    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
    ¿Objective response rate (ORR) per imaging assessment - Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by independent central imaging facility review based on RECIST version 1.1
    Tasso di risposta obiettiva (ORR) valutato sulla base della diagnostica per immagini - La percentuale di partecipanti con risposta obiettiva viene valutata ogni sei settimane dal Ciclo 1 Giorno 1 fino alla progressione della malattia attraverso una revisione centrale indipendente della struttura di diagnostica per immagini in base alla versione 1.1 dei criteri RECIST
    E.2.2Secondary objectives of the trial
    ¿Duration of response
    ¿Best percent change in the sum of diameters of measurable tumors
    ¿Disease control rate (DCR)
    ¿Clinical benefit rate (CBR)
    ¿Progression-free survival
    ¿Overall survival (OS)
    ¿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 plasma/serum concentration (Cmax)
    ¿Time to Cmax (Tmax)
    ¿Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast)
    ¿AUC from the time of dosing until day 21 (AUC0-21d)
    ¿Durata della risposta
    ¿Migliore variazione percentuale nella somma dei diametri dei tumori misurabili
    ¿Tasso di controllo della malattia (DCR)
    ¿Tasso di beneficio clinico (CBR)
    ¿Sopravvivenza libera da progressione
    ¿Sopravvivenza complessiva (OS)
    ¿ORR valutato dallo sperimentatore in base alla versione 1.1 dei criteri RECIST
    Quanto segue si applica alle categorie DS-8201a, anticorpi anti-HER2 totali e MAAA-1181a:
    ¿Concentrazione plasmatica/sierica massima (Cmax)
    ¿Tempo alla Cmax (Tmax)
    ¿Area sotto la curva concentrazione/tempo (AUC) dalla somministrazione fino all¿ultima concentrazione quantificabile (AUClast)
    ¿AUC dal momento della somministrazione al Giorno 21 (AUC0-21g)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Men or women the age of majority in their country
    •Has pathologically documented breast cancer that:
    1.is unresectable or metastatic
    2.has HER2 positive expression confirmed per protocol
    •Has an adequate tumor sample
    •Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    •Has protocol-defined adequate cardiac, renal and hepatic function
    •Agrees to follow protocol-defined method(s) of contraception
    •Uomini o donne che abbiano raggiunto la maggiore età nel proprio Paese
    •Documentazione patologica di carcinoma mammario che:
    1.sia non resecabile o metastatico;
    2.presenti conferma di espressione positiva di HER2 secondo il protocollo
    •Disponibilità di un campione tumorale adeguato
    •Presenza di almeno una lesione misurabile secondo la versione 1.1. dei Criteri di valutazione della risposta nei tumori solidi (RECIST)
    •Funzionalità cardiaca, renale ed epatica adeguate secondo quanto definito nel protocollo
    •Consenso all’uso del/i metodo/i contraccettivo/i definito/i dal protocollo
    E.4Principal exclusion criteria
    •Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
    •Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
    •Has a medical history of clinically significant lung disease
    •Is suspected to have certain other protocol-defined diseases based on imaging at screening period
    •Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
    1.safety or well-being of the participant or offspring
    2.safety of study staff
    3.analysis of results
    •Anamnesi medica di infarto del miocardio, insufficienza cardiaca congestizia (CHF) sintomatica (Classi II-IV secondo la New York Heart Association [NYHA]), angina instabile o grave aritmia cardiaca
    •Prolungamento del QTc >450 millisecondi (ms) per gli uomini e >470 ms per le donne
    •Anamnesi medica di malattia polmonare clinicamente significativa
    •Sospetto di altre patologie specifiche definite nel protocollo sulla base degli esami di diagnostica per immagini condotti nel periodo di screening
    •Anamnesi di qualsivoglia patologia, malattia metastatica, uso di sostanze/farmaci o altra condizione che, secondo il protocollo o nel parere dello sperimentatore, potrebbe compromettere:
    1.la sicurezza o il benessere del partecipante o della prole
    2.la sicurezza del personale dello studio
    3.l’analisi dei risultati
    E.5 End points
    E.5.1Primary end point(s)
    ORR assessed by independent central imaging facility review based on RECIST version 1.1.
    ORR valutato attraverso una revisione centrale indipendente della struttura di diagnostica per immagini in base alla versione 1.1 dei criteri RECIST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    22 months
    22 mesi
    E.5.2Secondary end point(s)
    Secondary endpoints include: a) Duration of response, best percent change in the sum of diameters of measurable tumors, DCR, clinical benefit ratio (CBR), PFS, OS, and ORR assessed by the investigator based on RECIST version 1.1. b) Maximum plasma/serum concentration (Cmax), Time to Cmax (Tmax), Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast), AUC from the time of dosing until day 21 (AUC0-21d)
    End poin secondario include: a) Durata della risposta, migliore variazione percentuale nella somma dei diametri dei tumori misurabili, DCR, tasso di beneficio clinico (CBR), PFS, OS e ORR valutato dallo sperimentatore in base alla versione 1.1 dei criteri RECIST b) Concentrazione plasmatica/sierica massima (Cmax), tempo alla Cmax (Tmax), area sotto la curva concentrazione/tempo (AUC) dalla somministrazione fino all¿ultima concentrazione quantificabile (AUClast), AUC dal momento della somministrazione fino al Giorno 21 (AUC0-21g)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For endpoints: a) 22 months b) 21 days
    various time points thought the trial
    Per gli endpoint: a) 22 mesi b) 21 giorni
    diversi punti temporali durante il trial
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    open label
    open label
    E.8.2.4Number of treatment arms in the trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    Korea, Republic of
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    LVLS
    LVLP
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 207
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 230
    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)
    As defined in protocol
    Come definito nel protocollo
    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 Decision2018-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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