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    Summary
    EudraCT Number:2017-003908-50
    Sponsor's Protocol Code Number:EORTC-1709-BTG
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003908-50
    A.3Full title of the trial
    A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma.
    Ensayo en fase III de marizomib en combinación con radioquimioterapia estándar basada en temozolomida frente a radioquimioterapia estándar sola basada en temozolomida en pacientes con glioblastoma de diagnóstico reciente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase III study with marizomib in addition to standard of care in patients with brain cancer (glioblastoma).
    Estudio aleatorizado de fase III con marizomib además del tratamiento estándar en pacientes con cáncer de cerebro(glioblastoma).
    A.4.1Sponsor's protocol code numberEORTC-1709-BTG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03345095
    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 SponsorEuropean Organisation for research and Treatment of cancer (EORTC)
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Organisation for research and Treatment of cancer (EORTC)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportCelgene International
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for the Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 Avenue E. Mounier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1020
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741013
    B.5.5Fax number+3227727063
    B.5.6E-mailregulatory@eortc.org
    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 nameMarizomib
    D.3.2Product code 437742-34-2
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNMARIZOMIB
    D.3.9.1CAS number 437742-34-2
    D.3.9.3Other descriptive nameSalinosporamide A
    D.3.9.4EV Substance CodeSUB177939
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 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
    Glioblastoma
    Glioblastoma
    E.1.1.1Medical condition in easily understood language
    Most aggressive and most common primary brain tumor
    el más agresivo y común de los cánceres primaries del cerebro
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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
    The primary objective of this study is to compare overall survival in patients receiving Marizomib in combination with standard treatment with patients receiving standard treatment only.
    El objetivo principal de este estudio es comparar la supervivencia global en pacientes que reciben Marizomib en combinación con el tratamiento estándar con pacientes que reciben sólo el tratamiento estándar.
    E.2.2Secondary objectives of the trial
    Secondary objective is to compare PFS in the two treatment arms in the whole population.
    El objetivo secundario es comparar la supervivencia sin progresión (SSP) en los dos grupos de tratamiento en la población total.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Neurocognitive testing, imaging.
    Pruebas neurocognitivas, imágenes.
    E.3Principal inclusion criteria
    - Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
    - Tumor resection (gross total or partial), or biopsy only
    - Availability of FFPE tumor block or 24 unstained slides for MGMT analysis
    - Patient must be eligible for standard TMZ/RTTMZ
    - Karnofsky performance score (KPS) ≥ 70 (Appendix E)
    - Recovered from effects of surgery, postoperative infection and other complications of surgery (if any)
    - The patient is at least 18 years of age on day of signing informed consent
    - Stable or decreasing dose of steroids for at least 1 week prior to inclusion
    - The patient has a life expectancy of at least 3 months
    - Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy)
    - The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function
    - Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment.
    - Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 6 months after receiving the last dose of study treatment.
    - Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
    - Ability to take oral medication
    - Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
    - Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    • Glioblastoma de nuevo diagnóstico histológicamente confirmado (grado IV de la OMS)
    • Resección tumoral (macroscópica total o parcial) o solamente biopsia
    • Disponibilidad de bloque tumoral en FFPE o 24 frotis sin teñir para el análisis de MGMT
    • El paciente debe ser apto para el tratamiento de referencia TMZ/RTTMZ
    • Puntuación del estado funcional de Karnofsky (PFK) ≥70
    • Recuperación de los efectos de la cirugía, infección posoperatoria y otras complicaciones quirúrgicas (si las hubiera)
    • El paciente tiene al menos 18 años de edad el día de la firma del consentimiento informado
    • Dosis estable o decreciente de corticoesteroides durante al menos 1 semana antes de la inclusión
    • El paciente tiene una esperanza de vida de al menos 3 meses
    • El paciente se ha sometido a una RMN cerebral en los 14 días anteriores a la aleatorización y después de la intervención (resección o biopsia)
    • El paciente muestra funciones orgánicas adecuadas según la evaluación de los valores analíticos especificados en las 2 semanas anteriores a la aleatorización, definidos como una función adecuada de la médula ósea, renal y hepática dentro de los siguientes intervalos:
    • LEU ≥3×109/l
    • RAN ≥1,5×109/l
    • Recuento de plaquetas ≥100×109/l con independencia de que se reciba transfusión
    • Hemoglobina ≥10 g/dl
    • Bilirrubina total ≤1,5 LSN
    • ALT, AST, fosfatasa alcalina (FA) ≤2,5 × LSN
    • Creatinina sérica <1,5 x LSN o aclaramiento de creatinina (CrCl) >30 ml/min (usando la fórmula de Cockcroft-Gault)
    • Las mujeres en edad fértil (MEF) deben tener una prueba de embarazo en orina o suero negativa dentro de los 7 días previos a la primera dosis del tratamiento del estudio.
    • Las pacientes en edad fértil/con capacidad para concebir deben acceder a utilizar métodos anticonceptivos adecuados, de acuerdo con lo definido por el investigador, durante el periodo de tratamiento del estudio y durante al menos 6 meses tras la última dosis del tratamiento del estudio. Un método de regulación de la natalidad altamente eficaz se define como aquel que tiene una baja tasa de fallo (es decir, inferior al 1 % anual) cuando se usa de manera sistemática y correcta. Los pacientes deben aceptar además no donar esperma durante el estudio y durante los 6 meses posterioresde haber recibido la última dosis del tratamiento del estudio.
    • Las mujeres que estén en periodo de lactancia, deben acceder a interrumpirlo antes de la primera dosis del tratamiento del estudio y hasta 6 meses después del último tratamiento del estudio.
    • Capacidad para tomar medicamentos orales
    • Capacidad para comprender los requisitos del estudio, proporcionar el consentimiento informado por escrito y la autorización para el uso y divulgación de información de salud protegida y acceder a cumplir las restricciones del estudio y acudir a las evaluaciones requeridas.
    • Antes del registro/la aleatorización del paciente, se debe dar el consentimiento informado por escrito conforme a las ICH/BPC y a los reglamentos nacionales/locales.
    E.4Principal exclusion criteria
    - Patients with known IDH mutation (IDH mutation testing should be considered for younger patients or patients with tumors with atypical features)
    - Prior treatment for glioblastoma other than surgery; prior RT to brain and/or prior chemotherapy for lower grade glioma. Placement of BCNU wafer during surgery is not allowed
    - Planned additional treatment with Tumor-Treating Fields
    - Known hypersensitivity to the active substance or any of the excipients in the IV formulation
    - History of thrombotic or hemorrhagic stroke or myocardial infarction in past 6 months
    - Congestive heart failure (New York Heart Association Class III to IV, see Appendix C), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, and myocardial infarction within 6 months prior to first dose
    - Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, hypertension, coronary artery disease, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
    - Known history or current evidence of active Hepatitis B (e.g., positive HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected)
    - Known or current evidence of Human Immunodeficiency Virus (HIV) (positive HIV-1/2 antibodies)
    - Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml). Other cancers for which the subject has completed potentially curative treatment more than 3 years prior to study entry are allowed.
    - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Pacientes con mutación de IDH conocida (la prueba de mutación de IDH debería considerarse en pacientes jóvenes o con tumores con características atípicas)
    • Tratamiento previo para el glioblastoma diferente de la cirugía; RT previa al cerebro y/o quimioterapia previa para glioma de bajo grado. No se permite la colocación de implantes de BCNU durante la cirugía
    • Tratamiento adicional programado con terapia de campo de tumores (Tumor-Treating Fields)
    • Hipersensibilidad conocida al principio activo o a cualquiera de los excipientes de la formulación i.v.
    • Antecedentes de accidente cerebrovascular trombótico o hemorrágico o infarto de miocardio en los últimos 6 meses
    • Insuficiencia cardíaca congestiva (clase III a IV de la New York Heart Association), isquemia sintomática, anomalías de la conducción no controladas mediante intervención convencional e infarto de miocardio en los 6 meses anteriores a la primera dosis
    • Enfermedad médica concurrente grave o no controlada (p. ej., infección sistémica activa, diabetes, hipertensión, arteriopatía coronaria, trastorno psiquiátrico) que, a criterio del investigador, comprometería la seguridad del paciente o su capacidad para completar el estudio
    • Historial conocido o evidencia actual de hepatitis B (p. ej., antígeno de superficie de VHB positivo) o C (p. ej., ARN del VHC [cualitativo] detectado) activa
    • Infección conocida o evidente por el virus de la inmunodeficiencia humana (VIH) (anticuerpos frente a VIH-1/2)
    • Neoplasia maligna invasiva previa o segunda neoplasia maligna invasiva, excepto cáncer de piel no melanoma, cáncer de cuello de útero o próstata (con PSA inferior o igual a 0,1 ng/ml) completamente extirpado. Se permite cualquierotro cáncer para el que el paciente haya recibido tratamiento potencialmente curativo más de 3 años antes de entrar en el estudio.
    • Presencia de cualquier afección psicológica, familiar, sociológica o geográfica que pudiera potencialmente afectar al cumplimiento del protocolo del estudio y el calendario de seguimiento; estas afecciones deben comentarse con el paciente antes de llevar a cabo el registro en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is Overall Survival
    El criterio de valorisación principal es la supervivencia general
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the date of randomization up to the date of death, assessed up to 49 months
    Desde la fecha de aleatorización hasta la fecha de fallecimiento, evaluada hasta 49 meses
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    1. Progression free survival
    2. Quality of Life (modified EORTC QLQ C30/BN20)
    3. Mini Mental State Examination (MMSE)
    4. Frequencies and percentages of worst Adverse Events (AEs) or Laboratory Event grades
    Los criterios de valorisación secundaria incluyen:
    1. Supervivencia libre de progression
    2. Calidad de vida (EORTC QLQ C30/BN20)
    3. MMSE
    4. Frecuencias y porcentajes de los peores eventos adversos (EA) o grados de eventos de laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months.
    2. From randomization until progression, assessed up to 49 months.
    3. From the date of randomization until end of treatment, assessed up to 49 months
    4. From the date of randomization until end of treatment, assessed up to 49 months
    1. Desde la fecha de aleatorización hasta la fecha de la primera progresión objetiva o la fecha de fallecimiento del paciente, lo que ocurra primero, evaluado hasta 49 meses.
    2. Desde la aleatorización hasta la progresión, evaluada hasta 49 meses.
    3. Desde la fecha de aleatorización hasta el final del tratamiento, evaluado hasta 49 meses
    4. Desde la fecha de aleatorización hasta el final del tratamiento, evaluado hasta 49 meses
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Surgery, Radiotherapy, Biobanking, QoL, Translational Research
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    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 months1
    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: 592
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 750
    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)
    The treatment will be left to the discretion of the treating physician.
    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 Decision2018-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
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