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    Summary
    EudraCT Number:2017-003493-13
    Sponsor's Protocol Code Number:BGB-290-303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003493-13
    A.3Full title of the trial
    A Phase 3, Double-blind, Randomized Study of BGB-290 versus Placebo as Maintenance Therapy in Patients with Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy
    Estudio de fase 3, en doble ciego y aleatorizado, de BGB-290 frente a placebo como tratamiento de mantenimiento en pacientes con cáncer gástrico localmente avanzado o metastásico, inoperable, que han respondido a una quimioterapia de primera línea basada en el platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating efficacy of the drug BGB-290 in patients with gastric cancer that responded to previous chemotherapy.
    Estudio para evaluar la eficacia del medicamento BGB-290 en pacientes con cáncer gástrico que han respondido a una quimioterapia previa.
    A.4.1Sponsor's protocol code numberBGB-290-303
    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.
    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 Ltd.
    B.5.2Functional name of contact pointClinical Trial Information Email
    B.5.3 Address:
    B.5.3.1Street Addressc/o BeiGene USA, Inc. 1900 Powell Street
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post codeCA 94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781801 1800
    B.5.6E-mailclinicaltrials@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.3.2Product code BGB-290
    D.3.4Pharmaceutical form Capsule
    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 INNBGB-290
    D.3.9.2Current sponsor codeBGB-290
    D.3.9.4EV Substance CodeSUB188812
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy
    Cáncer gástrico inoperable localmente avanzado o metastásico que presente respuesta tras una quimioterapia de primera línea basada en el platino
    E.1.1.1Medical condition in easily understood language
    Metastatic Gastric Cancer
    Cáncer gástrico metastásico
    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 PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of maintenance therapy with BGB-290 versus placebo in patients with inoperable locally advanced or metastatic gastric cancer with a complete response (CR) or confirmed partial response (PR) after first-line platinum-based chemotherapy, as measured by:
    Progression-free survival (PFS) by Blinded Independent Review Committee (BIRC) assessment.
    Evaluar la eficacia del tratamiento de mantenimiento con BGB-290 en comparación con placebo en pacientes con cáncer gástrico localmente avanzado o metastásico, inoperable, con respuesta completa (complete response, CR) o respuesta parcial (partial response, PR) confirmada tras una quimioterapia de primera línea basada en el platino, en su medición por:
    o Supervivencia sin progresión (progression-free survival, PFS), en su
    determinación por un comité de revisión desconocedor del tratamiento e independiente (Blinded Independent Review Committee, BIRC)
    E.2.2Secondary objectives of the trial
    To further evaluate the efficacy of maintenance therapy with BGB-290 versus placebo in patients with inoperable locally advanced or metastatic gastric cancer with a CR or confirmed PR after first-line platinum-based chemotherapy, as measured by:
    * Overall survival (OS)
    * PFS by investigator assessment
    * Progression-free survival 2 (PFS2) by investigator assessment
    * Time to second subsequent treatment (TSST) by investigator assessment
    * Objective response rate (ORR; CR or PR) by investigator assessment
    * Duration of response by investigator assessment
    * Time to response by investigator assessment
    To evaluate safety and tolerability of BGB-290 versus placebo, as measured by:
    * Incidence, timing, and severity of treatment-emergent adverse events (TEAEs), graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 or higher
    Evaluar ulteriormente la eficacia del tratamiento de mantenimiento con BGB-290 en comparación con placebo en pacientes con cáncer gástrico localmente avanzado o metastásico, inoperable, con una respuesta completa o una respuesta parcial confirmada tras quimioterapia de primera línea basada en el platino, en su medición por:
    -Supervivencia global (overall survival, OS)
    -Supervivencia sin progresión (PFS)
    -Supervivencia sin progresión 2 (PFS2)
    -Tiempo hasta el segundo tratamiento posterior (time to second subsequent treatment, TSST)
    -Tasa de respuesta objetiva ( respuesta completa o respuesta parcial)
    -Duración de la respuesta
    -Tiempo hasta la respuesta
    Evaluar la seguridad y la tolerabilidad de BGB-290 en comparación con placebo, en su medición mediante:
    -Incidencia, momento y severidad de los acontecimientos adversos surgidos durante el tratamiento, en su clasificación por grados según los criterios NCI-CTCAE, Versión 4.03 o superior.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be eligible for the study:
    1) Age 18 years
    2) Histologically proven adenocarcinoma of the stomach or gastroesophageal junction, inoperable locally advanced or with metastatic disease
    a) Patients with gastric cancer overexpressing HER2 are not allowed.
    b) Irradiation as part of prior first-line treatment is not allowed.
    3) Availability of archival tumor tissue for central laboratory determination of HRD status for randomization and exploratory biomarker analyses
    4) Confirmed PR that is maintained for >=4 weeks or CR as determined by the investigator per RECIST Version 1.1
    Los pacientes deben cumplir todos los criterios siguientes para ser elegibles para el ensayo:
    1) >o= 18 años de edad
    2) con adenocarcinoma de estómago o de la unión gastroesofágica, demostrado histológicamente, con enfermedad localmente avanzada o metastásica, inoperable.
    a) No se admitirán pacientes con cáncer gástrico con sobreexpresión de HER2
    b) No se admitirán pacientes que hayan recibido radioterapia como parte del tratamiento de primera línea previo.
    3) Se precisa disponer de una muestra de tejido tumoral de archivo para determinación en el laboratorio central del estado en cuanto a HRD, a fines de estratificación y para análisis exploratorio de biomarcadores.
    4) Confirmación de respuesta parcial mantenida durante ≥4 semanas o una respuesta completa determinada por el investigador mediante RECIST versión 1.1.
    E.4Principal exclusion criteria
    1) Unresolved acute effects of prior therapy of Grade ≥2
    2) Prior treatment with a PARP inhibitor
    3) Chemotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤14 days prior to randomization
    4) Diagnosis of MDS
    5) Leptomeningeal disease or brain metastasis
    6) Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome
    7) Active bleeding disorder
    1) efectos agudos sin resolver de la terapia previa de grado ≥ 2
    2) tratamiento previo con un inhibidor PARP
    3) quimioterapia, terapia biológica, la inmunoterapia, agentes en investigación, medicina china contra el cáncer o remedios de herbolario contra el cáncer ≤14 días antes de la aleatorización
    4) diagnóstico de MDS
    5) Enfermedad leptomeníngea o metástasis cerebral
    6) resección gástrica completa previa, diarrea crónica, enfermedad gastrointestinal inflamatoria activa o cualquier otra enfermedad que cause el síndrome de malabsorción
    7) trastornos hemorrágicos activos
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
    Supervivencia sin progresión (progression-free survival, PFS), en su
    determinación por un comité de revisión desconocedor del tratamiento e independiente (Blinded Independent Review Committee, BIRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    For PFS, there will be 1 planned interim analysis. The interim analysis will be performed when 242 PFS events (66.7% of the final target number of PFS events) have occurred at approximately 23 months after start of randomization, and the final analysis will be performed when 363 PFS events have occurred at approximately 29 months after start of randomization.
    Se ha previsto realizar un análisis intermedio de la supervivencia sin progresión una vez que se hayan producido 242 acontecimientos de la supervivencia sin progresión (el 66,7% del número final programado de acontecimientos de la supervivencia sin progresión), lo que tendrá lugar aproximadamente 23 meses después del inicio de la aleatorización, mientras que el análisis final se efectuará una vez que se hayan producido 363 acontecimientos de la supervivencia sin progresión, lo que tendrá lugar aproximadamente 29 meses después del inicio de la aleatorización.
    E.5.2Secondary end point(s)
    Overall survival (OS)
    Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    There will be 1 interim analysis of OS at the final of PFS analysis. The interim analysis will be performed at the final PFS analysis with positive PFS results and expected 285 deaths. The final analysis will be performed when 390 deaths have occurred.
    Habrá un análisis intermedio de la supervivencia global, a practicar en el momento del análisis final de la supervivencia sin progresión con los resultados de esta positivos y una previsión de 285 muertes. El análisis final de la supervivencia global se llevará a cabo con el objetivo de 390 muertes.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Australia
    Belgium
    China
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Japan
    Poland
    Russian Federation
    Singapore
    Spain
    Taiwan
    United Kingdom
    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
    Última visita del ultimo paciente
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 144
    F.4.2.2In the whole clinical trial 540
    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)
    There are no plans to provide study treatment after termination of the study. Patients can return to their usual medication after completing the study. The Investigator is responsible for ensuring that consideration has been given to the post-study medical care of the patient's medical condition.
    No hay planes para proporcionar tratamiento de estudio después de la finalización del estudio. Los pacientes pueden volver a su medicación habitual después de completar el estudio. El investigador será responsable de asegurar que se ha prestado atención a los cuidados médicos necesarios para la condición médica del paciente tras el estudio.
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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