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    Summary
    EudraCT Number:2017-003466-28
    Sponsor's Protocol Code Number:DS8201-A-J203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-14
    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 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
    Studio di fase 2, multicentrico, in aperto, che mira a valutare DS-8201a in soggetti affetti da carcinoma del colon-retto in stadio avanzato che esprime il recettore 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
    Studio di fase 2, multicentrico, in aperto, che mira a valutare DS-8201a in soggetti affetti da carcinoma del colon-retto in stadio avanzato che esprime il recettore 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 pointNA
    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 number0019089926400
    B.5.5Fax number0019089926400
    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 NA
    D.3.4Pharmaceutical form Powder and solvent 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
    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
    Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancer
    Cancro al colon-retto in fase avanzata che esprime HER2.
    E.1.1.1Medical condition in easily understood language
    Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancer
    Cancro al colon-retto in fase avanzata che esprime HER2.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    Determinare il tasso di risposta obiettiva (Objective Response Rate, ORR) di DS-8201a nei pazienti affetti da carcinoma del colon-retto in stadio avanzato, metastatico con espressione di 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
    ¿ Stimare la durata della risposta (Duration of Response, DoR), il tasso di controllo della malattia (Disease Control Rate, DCR), la sopravvivenza senza progressione (Progression-Free Survival, PFS) e la sopravvivenza globale (Overall Survival, OS). Sar¿ inoltre valutata l¿ORR stimata dallo sperimentatore.
    ¿ Valutare la sicurezza di DS-8201a
    ¿ Determinare l¿analisi farmacocinetica (PK) di DS-8201a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pathologically documented unresectable, recurrent, or metastatic
    colorectal adenocarcinoma. Until sponsor's notification to the study
    sites, subject must be a (BRAF) wild-type cancer.
    2. Received at least 2 prior regimens of standard treatment.
    3. Has measurable disease assessed by the investigator based on RECIST
    version 1.1.
    4. Has an Eastern Cooperative Oncology Group Performance Status (ECOG
    PS) of 0 to 1
    1. Adenocarcinoma del colon-retto non resecabile, recidivante o metastatico, documentato dal punto di vista patologico. Fino alla notifica dello sponsor ai centri dello studio, il soggetto deve presentare un tumore ”wild-type” per BRAF.
    2. Trattamento con almeno 2 regimi di trattamento standard in precedenza.
    3. Ha una malattia misurabile verificata dallo sperimentatore sulla base dei RECIST V 1.1
    4. Ha un ECOG PS da 0 a 1
    E.4Principal exclusion criteria
    1. Medical history of myocardial infarction within 6 months before enrollment (study treatment), symptomatic congestive heart failure
    2 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
    3. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
    1. Anamnesi di infarto miocardico nei 6 mesi precedenti l'arruolamento (trattamento dello studio), insufficienza cardiaca congestizia sintomatica
    2. Ha avuto ILD/polmonite (non infettiva) che ha richiesto il trattamento con steroidi, soffre attualmente di ILD/polmonite o si sospetta tale malattia sulla base degli esami per immagini durante il periodo di screening
    3. Compressione del midollo spinale o metastasi clinicamente attive al sistema nervosa central, definite come non trattate e sintomatiche, o che richiedono terapie
    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
    Tasso di risposta oggettivo (ORR) basato sui test per immagini - Percentuale di partecipanti con risposta oggettiva basata sui dati del laboratorio centralizzato per le immagini (criteri per la valutazione della risposta in t umori solidi - RECIST) versione 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 wekks
    Ogni 6 settimane
    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)
    ¿Sopravvivenza libera da progression
    ¿Sopravvivenza complessiva
    ¿Durata della risposta
    ¿Tasso di controllo della malattia (DCR)
    ¿ORR valutata dallo sperimentatore sulla base dei RECIST versione 1.1

    I seguenti si applicano alle categorie; DS-8201a, anticorpo anti-HER2 totale
    e MAAA-1181a
    ¿Massima concentrazione plasma/siero (Cmax)
    ¿ Tempo per raggiungere la Cmax (Tmax)
    ¿Area sotto la curva (AUC)
    ¿AUC dal momento della somministrazione fino al giorno 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
    Ogni 6 settimane per efficacia, OSfino alla morte o all'ultimo contatto con il paziente
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Lo studio non è controllato, ma il sistema impedisce di andare oltre se non si clicca "Sì" al punto
    The trial is not controlled, but the system impedes you to go further if point E.8.1 is "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
    NA
    NA
    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 concerned4
    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 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
    Japan
    United States
    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
    End of OS follow-up
    Fine del follow-up per OS.
    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 state9
    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)
    NA
    NA
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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