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    Summary
    EudraCT Number:2019-001512-34
    Sponsor's Protocol Code Number:DS8201-A-U205
    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:2021-02-01
    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 number2019-001512-34
    A.3Full title of the trial
    PHASE 2, OPEN-LABEL, SINGLE-ARM TRIAL OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN HER2-POSITIVE, UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA SUBJECTS WHO HAVE PROGRESSED ON OR AFTER A TRASTUZUMAB-CONTAINING REGIMEN
    Studio di fase 2, in aperto, a braccio singolo di trastuzumab deruxtecan (DS-8201a) in soggetti con adenocarcinoma HER2 positivo, non resecabile o metastatico gastrico o della giunzione gastro-esofagea (GGE) che hanno manifestato una progressione durante o dopo un regime contenente 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 in tumori gastrici HER-2 positivi non asportabili chirurgicamente o diffusi
    A.3.2Name or abbreviated title of the trial where available
    DS-8201a in HER2-positive Gastric Cancer that cannot be surgically removed or has spread
    DS-8201a in tumori gastrici HER-2 positivi non asportabili chirurgicamente o diffusi
    A.4.1Sponsor's protocol code numberDS8201-A-U205
    A.5.4Other Identifiers
    Name:136179Number:IND
    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 pointDaiichi Sankyo Inc.
    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 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 [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 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.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 or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma that has progressed on or after a trastuzumabcontaining regimen
    adenocarcinoma non resecabile o adenocarcinoma metastatico gastrico o adenocarcinoma della giunzione gastro-esofagea (GGE) che ha manifestato una progressione durante o dopo un regime contenente trastuzumab
    E.1.1.1Medical condition in easily understood language
    HER2-POSITIVE, UNRESECTABLE OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA
    adenocarcinoma HER2 positivo, non resecabile o metastatico gastrico o della giunzione gastro-esofagea (GGE)
    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
    Studiare l’efficacia di trastuzumab deruxtecan in base al tasso di risposta obiettiva (ORR), attraverso una revisione centrale indipendente sulla base dei Criteri di valutazione della risposta nei tumori solidi (RECIST) versione (v) 1.1
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of Trastuzumab Deruxtecan on progressionfree 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)
    • Valutare l’efficacia dell'IMP sulla sopravvivenza libera da progressione (PFS), in base a una revisione centrale indipendente usando i criteri RECIST v1.1.
    Altri obiettivi_
    • Valutare ulteriormente l’efficacia dell'IMP utilizzando l’endpoint della sopravvivenza complessiva (OS)
    • Valutare ulteriormente l’efficacia dell'IMP utilizzando i criteri RECIST v1.1 per gli endpoint di PFS e tasso di risposta obiettiva (ORR) in base alla valutazione dello sperimentatore, e della durata della risposta (DoR) in base alla revisione centrale indipendente e alla valutazione dello sperimentatore
    • Determinare la farmacocinetica (PK) dell'IMP nel siero
    • Valutare ulteriormente la sicurezza dell'IMP sulla base di eventi avversi emergenti dal trattamento (TEAE) e anticorpi anti-farmaco (ADA)
    • Valutare gli endpoint Health Economics and Outcomes Research (HEOR) in base agli esiti riferiti dai pazienti (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    • Uomini o donne di età =18 anni (La preghiamo di seguire i requisiti normativi locali, se la maggiore età di consenso per la partecipazione allo studio è >18 anni.)
    • Presenta tumore gastrico o GGE documentato dal punto di vista patologico con le seguenti caratteristiche:
    ¿ Non resecabile o metastatico
    ¿ Malattia HER2 positiva confermata a livello centrale (immunoistochimica [IHC]3+, ibridazione IHC2+/in-situ [ISH]+) come determinato in base alle linee guida dell’American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) in base a un nuovo campione di tessuto ottenuto in seguito a progressione durante o dopo un regime contenente trastuzumab. Se, dopo la sospensione del trattamento di prima linea con un regime contenente trastuzumab, è già stato prelevato un campione di tessuto, è accettabile prenderlo in considerazione come nuova biopsia ai fini di questo studio.
    • Progressione della malattia che si è manifestata durante o dopo la terapia di prima linea con un regime contenente trastuzumab (o biosimilare approvato). Nota: Una precedente terapia adiuvante con un regime contenente trastuzumab può essere considerata come una linea di terapia se il soggetto ha avuto una progressione a, o entro, 6 mesi dal completamento della terapia adiuvante.
    • Presenta almeno 1 lesione misurabile secondo i criteri RECIST v1.1 come confermato dalla revisione centrale indipendente.
    • Presenta frazione di eiezione ventricolare sinistra (FEVS) =50% nei 28 giorni precedenti l’arruolamento per ecocardiogramma (ECO)/scansione con acquisizione a gate multipli (MUGA).
    • I soggetti di sesso maschile e femminile potenzialmente fertili devono accettare di usare un metodo contraccettivo altamente efficace o evitare rapporti sessuali durante e al completamento dello studio per almeno 4,5 mesi dopo l’ultima dose del farmaco dello studio.
    • Adeguata funzionalità renale, definita come clearance della creatinina =30 ml/min, calcolata utilizzando l’equazione di Cockcroft Gault.
    • Funzione epatica adeguata, definita come bilirubina totale =1,5 × il limite superiore della norma (ULN); albumina sierica =2,8 g/dl; aspartato transaminasi (AST)/alanina transaminasi (ALT) =3 × l’ULN in assenza di metastasi epatiche o =5 × l’ULN in presenza di metastasi epatiche.
    E.4Principal exclusion criteria
    - Use of anticancer therapy after first-line treatment with a trastuzumabcontaining 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 di terapia antitumorale dopo il trattamento di prima linea con un regime contenente trastuzumab.
    • Malattia cardiovascolare non controllata o significativa, inclusa una qualsiasi delle seguenti:
    ¿ Anamnesi di infarto miocardico (IM) nei 6 mesi precedenti l’arruolamento
    ¿ Anamnesi di insufficienza cardiaca congestizia sintomatica (classe II-IV secondo la New York Heart Association)
    ¿ Livelli di troponina coerenti con un’eziologia di IM, in base alla definizione del produttore, nei 28 giorni precedenti l’arruolamento
    ¿ Anamnesi di angina instabile o grave aritmia cardiaca che richieda trattamento
    ¿ Prolungamento dell’intervallo QT corretto (QTc) >470 ms (soggetti di sesso femminile) o >450 ms (soggetti di sesso maschile) in base a Screening per mezzo di elettrocardiogramma a 12 derivazioni (ECG) in triplicato
    • Anamnesi di malattia polmonare interstiziale (ILD) o polmonite (non infettiva) che ha richiesto una terapia a base di corticosteroidi, o polmonite/ILD corrente o sospetta in base all’esame diagnostico per immagini durante lo Screening.
    • Malattia della cornea clinicamente significativa, in base al giudizio dello sperimentatore.
    • Effusione pleurica, ascite, o effusione pericardica che richiede drenaggio, shunt peritoneale, o Terapia di reinfusione per l’ascite libera circolante e concentrata (Cell-free and Concentrated Ascites Reinfusion Therapy, CART). (Il drenaggio e la CART non sono consentiti nelle 2 settimane precedenti, o durante, lo Screening.)
    • Compressione del midollo spinale o metastasi a carico del sistema nervoso centrale clinicamente attive, definite come non trattate e sintomatiche o che richiedano terapia con corticosteroidi o anticonvulsivanti per il controllo dei sintomi associati.
    ¿ I soggetti con metastasi cerebrali clinicamente inattive possono essere inclusi nello studio.
    ¿ I soggetti con metastasi cerebrali trattate che non sono più sintomatiche e che non richiedono il trattamento con corticosteroidi o anticonvulsivanti possono essere inclusi nello studio se si sono ripresi dagli effetti tossici acuti della radioterapia. Devono essere trascorse almeno 2 settimane tra la fine della radioterapia sull’intero cervello e l’arruolamento nello studio (1 settimana per la radioterapia stereotassica).
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed ORR (objective response rate) based on independent central review
    ORR confermato, basato sulla revisione centrale indipendente
    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.
    L'analisi dell'ORR verrà eseguita per tutti i soggetti arruolati a 18 settimane dalla valutazione del tumore
    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
    PFS, basata sulla revisione centrale indipendente, utilizzando RECIST v1.1; Altri endpoint secondari
    • PFS, basata sulla valutazione dello sperimentatore
    • ORR, basato sulla valutazione dello sperimentatore
    • OS
    • Durata della risposta, in base alla revisione centrale indipendente e alla valutazione dello sperimentatore
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study. Based on independent central review; Along the study. Based on independent central review
    Durante lo studio, basata sulla revisione di un comitato centrale indipendente; Durante lo studio, basata sulla revisione di un comitato centrale indipendente
    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 Yes
    E.6.11Pharmacogenomic No
    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.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 No
    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 concerned5
    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 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
    United States
    Belgium
    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
    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
    la fine dello studio si verificherà quando tutti i soggetti arruolati avranno completato l'ultima visita programmata o sono deceduti o ritirati dallo studio, il che si prevede che si verifichi circa 12 mesi dopo l'arruolamento dell'ultimo soggetto
    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 months6
    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 state10
    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
    Vedere 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 Decision2019-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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