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    Summary
    EudraCT Number:2017-002423-19
    Sponsor's Protocol Code Number:BGB-A317-301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-12
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002423-19
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 versus Sorafenib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma
    Étude multicentrique de phase III, randomisée, en ouvert, visant à comparer l’efficacité et la sécurité d’emploi du BGB-A317 par rapport au sorafénib dans le traitement de première intention chez des patients atteints d’un carcinome hépatocellulaire non résécable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of BGB-A317 Versus Sorafenib in Patients with Unresectable HCC
    Étude de phase III, du BGB-A317 versus sorafénib chez des patients atteints d’un carcinome hépatocellulaire non résécable
    A.4.1Sponsor's protocol code numberBGB-A317-301
    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 SponsorBeiGene, Ltd. c/o BeiGene USA, 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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Inc.
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.4CountryUnited States
    B.5.6E-mailBeigeneClinicalSupportUS@beigene.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 nameBGB-A317
    D.3.4Pharmaceutical form Concentrate 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 INNBGB-A317
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Nexavar 200 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNexavar
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSORAFENIB TOSYLATE
    D.3.9.1CAS number 475207-59-1
    D.3.9.4EV Substance CodeSUB22347
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Hepatocellular Carcinoma
    Carcinome hépatocellulaire non résécable
    E.1.1.1Medical condition in easily understood language
    Unresectable Hepatocellular Carcinoma is a specific type of Liver cancer that is unable to be removed by surgery.
    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 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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 compare OS between BGB-A317 and sorafenib as first-line treatment in patients with unresectable HCC
    Comparer la survie globale (SG) entre le BGB-A317 et le sorafénib comme traitement de première ligne chez des patients atteints d’un carcinome hépatocellulaire (CHC) non résécable
    E.2.2Secondary objectives of the trial
    •To compare ORR assessed by Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria in Solid Tumors [RECIST]) Version (v)1.1 between BGB-A317 and sorafenib
    • To compare progression-free survival (PFS) assessed by BIRC according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare DOR assessed by BIRC according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare time to progression (TTP) between BGB-A317 and sorafenib
    • To compare health-related quality of life (HRQoL) between BGB-A317 and sorafenib
    • To compare tumor assessment outcomes (ie, ORR, PFS, DOR, TTP) assessed by Investigator according to RECIST v1.1 between BGB-A317 and sorafenib
    • To compare disease control rate (DCR) and clinical benefit rate (CBR), assessed by BIRC and Investigator according to RECIST v1.1, between BGB-A317 and sorafenib
    • To compare safety and tolerability of BGB-A317 versus sorafenib
    •Comparer le taux de réponse objective (TRO) évalué par un comité d’examen indépendant en aveugle (BIRC) conformément aux critères d’évaluation de la réponse dans les tumeurs solides (RECIST) Version 1.1 entre le BGB-A317 et le sorafénib.
    •Comparer la survie sans progression (SSP) évaluée par le BIRC entre le BGB-A317 et le sorafénib
    •Comparer la durée de réponse (DDR) évaluée par le BIRC entre le BGB-A317 et le sorafénib
    •Comparer le délai avant progression (DAP) entre le BGB-A317 et le sorafénib
    •Comparer la qualité de vie liée à la santé (QdVLS)
    •Comparer les résultats relatifs à l’évaluation de la tumeur (c.-à-d. TRO, SSP, DDR, DAP) évalués par l’investigateur selon les critères RECIST v1.1 entre le BGB-A317 et le sorafénib
    •Comparer le taux de contrôle de la maladie (TCM) et le taux de bénéfice clinique (TBC), évalués par le BIRC et l’investigateur selon les critères RECIST v1.1
    •Comparer la sécurité d’emploi et la tolérance du BGB-A317 comparativement au sorafénib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: SAFETY RUN-IN SUBSTUDY INVESTIGATING SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF ANTI-PD-1 MONOCLONAL ANTIBODY BGB-A317 IN JAPANESE PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA
    Protocol Identifier: BGB-A317-301 Substudy
    Primary Study Objectives:
    • To assess the safety and tolerability of BGB-A317 in Japanese patients with hepatocellular carcinoma (HCC)
    • To confirm the pivotal Phase 3 dose of BGB-A317 in Japanese patients
    • To characterize the pharmacokinetics of BGB-A317 in Japanese patients
    Secondary Study Objectives:
    • To assess the preliminary antitumor activity of BGB-A317
    • To assess host immunogenicity to BGB-A317
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of HCC
    2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
    3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
    4. Measurable disease
    5. Child-Pugh score A
    6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
    7. Adequate organ function
    1.Présenter un diagnostic de CHC confirmé par histologie
    2.Etre atteint(e) d’une maladie au stade C (BCLC) ou d’une maladie au stade B selon la BCLC qui ne se prête par à un traitement loco-régional ou a progressé après un tel traitement, et ne se prête pas à une approche de traitement curatif
    3.Ne pas avoir reçu de traitement systémique antérieur pour le CHC
    4.Présenter une lésion mesurable
    5.Présenter une classification Child-Pugh A
    6.Présenter un score PS ECOG ≤ 1
    7.Présenter une fonction organique adéquate

    E.4Principal exclusion criteria
    1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
    2. Tumor thrombus involving main trunk of portal vein or inferior vena cava
    3. Loco-regional therapy to the liver within 28 days before randomization
    4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
    5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
    6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
    7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
    8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
    9. QT interval corrected for heart rate (QTc) (corrected by Fridericia’s method) > 450 msec at Screening
    1.Présente un CHC fibrolamellaire, un CHC sarcomatoïde, une forme mixte associant un cholangiocarcinome à un CHC
    2.Présente un thrombus tumoral impliquant le tronc principal de la veine porte ou la veine cave inférieure
    3.A reçu dans les 28 jours précédant la randomisation un traitement loco-régional pour le foie
    4.Présente à la sélection, ou a présenté dans les 6 mois précédant la randomisation, toute preuve clinique d’hypertension portale accompagnée de varices Å“sophagiennes ou gastriques hémorragiques
    5.Présente à la sélection, ou a présenté dans les 6 mois précédant la randomisation, un saignement ou un trouble thrombotique ou a pris un anticoagulant prescrit nécessitant une surveillance thérapeutique du rapport normalisé international (INR) (par ex. warfarine ou agents similaires)
    6.Présente à la sélection un déficit immunitaire actif ou une maladie auto-immune et/ou a des antécédents de déficit immunitaire ou de maladie auto-immune qui pourrait rechuter
    7.Présente une maladie qui a nécessité un traitement systémique par corticoïdes (> 10 mg par jour de prednisone ou équivalent) ou par d’autres médicaments immunosuppresseurs dans les 14 jours précédant la randomisation
    8.Présente des antécédents de maladie pulmonaire interstitielle ou de pneumopathie inflammatoire non infectieuse, sauf si elle est induite par radiothérapie
    9.17.Présente des ECG à la sélection montrant un intervalle QT corrigé (QTc) pour la fréquence cardiaque (corrigé par la méthode de Fridericia) > 450 msec
    E.5 End points
    E.5.1Primary end point(s)
    • Overall Survival (OS) – defined as the time from the date of randomization to the date of death due to any cause
    •Survie globale (SG) - définie par le temps passé entre la date de randomisation et la date du décès pour quelque raison que ce soit
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS assessed by Blinded Independent Review Committee (BIRC)
    Survie globale (SG) définie par le BIRC
    E.5.2Secondary end point(s)
    • Overall Response Rate (ORR) as assessed by BIRC – defined as the proportion of patients with a documented CR or PR per RECIST v1.1
    • Progression-free survival (PFS)– defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1, or death, whichever occurs first
    • Duration of response (DOR) – defined as the time from the first determination of an objective response, assessed by BIRC per RECIST v1.1, until the first documentation of progression or death, whichever occurs first
    • Time to progression (TTP) – defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1
    • Health-related quality of life (HRQoL)
    • Tumor assessment (ie, ORR, PFS, DOR and TTP), assessed by Investigator per RECIST v1.1
    • Disease control rate (DCR) – defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by BIRC and Investigator per RECIST v1.1
    • Clinical benefit rate (CBR) – defined as the proportion of patients who have CR, PR, or SD of ≥ 24 weeks in duration, assessed by BIRC and Investigator per RECIST v1.1
    • Safety assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    • ORR by BIRC
    • PFS by BIRC
    • DOR by BIRC
    • TTP by BIRC
    • HRQoL
    • Tumor assessments (ORR, PFS, DOR, and TTP) assessed by Investigator per RECIST v1.1
    • DCR by BIRC and Investigator
    • CBR by BIRC and Investigator
    • Safety assessment (eg, new adverse events [AEs], AEs present at baseline that worsen in severity during the study, and clinical laboratory abnormalities)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    China
    European Union
    Japan
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 384
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 256
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 640
    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)
    Patients assigned to BGB-A317, who in the opinion of the Investigator, continue to benefit from BGB-A317 at study termination, may continue treatment after discussion and agreement by the Sponsor. For these patients, BGB-A317 will be provided by the Sponsor until they can be transitioned to commercial supply.
    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 Decision2018-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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