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    Summary
    EudraCT Number:2015-001166-26
    Sponsor's Protocol Code Number:M13-813
    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:2015-11-25
    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 number2015-001166-26
    A.3Full title of the trial
    A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)
    Estudio aleatorizado, controlado con placebo fase 2b/3 de ABT-414 con quimiorradiación concurrente y temozolomida adyuvante en pacientes recién diagnosticados de glioblastoma (GBM) con amplificación del receptor de factor de crecimiento epidermoide (EGFR) (Intellance 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Placebo Controlled Study of ABT-414 combined with Radiation and Temozolomide in Subjects with Newly Diagnosed Glioblastoma with Specific Tumor Markers
    Estudio aleatorizado, controlado con placebo de ABT-414 combinado con radiación y temozolomida en pacientes con glioblastoma de nuevo diagnóstico y marcadores tumorales específicos
    A.4.1Sponsor's protocol code numberM13-813
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901 20 01 03
    B.5.5Fax number+441628644330
    B.5.6E-mailabbvie_reec@abbvie.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1305
    D.3 Description of the IMP
    D.3.1Product nameABT-414
    D.3.2Product code ABT-414
    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 INNABT-414
    D.3.9.2Current sponsor codeABT-414
    D.3.9.3Other descriptive nameABT-414
    D.3.9.4EV Substance CodeSUB83643
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed glioblastoma (GBM) or gliosarcoma
    Glioblastoma de nuevo diagnóstico (GBM) o gliosarcoma
    E.1.1.1Medical condition in easily understood language
    Specific brain tumors known as glioblastoma, or GBM
    Tumores específicos de cerebro conocidos como glioblastoma, o GBM
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10006153
    E.1.2Term Brain tumor
    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
    Phase 2: to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs progression free survival (PFS) in subjects with newly diagnosed GBM harboring EGFR amplificaton. Phase 3: to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs overall survival (OS) in subjects with newly diagnosed GBM harboring EGFR amplificaton
    Fase 2: determinar si la adición de ABT-414 al tratamiento concurrente con radioterapia y temozolomida prolonga la supervivencia sin progresión (SSP) en sujetos con diagnóstico reciente de GBM con amplificación de EGFR. Fase 3: determinar si la adición de ABT-414 al tratamiento concurrente con radioterapia y temozolomida prolonga la supervivencia global (SG) en sujetos con diagnóstico reciente de GBM con amplificación de EGFR
    E.2.2Secondary objectives of the trial
    To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide improves outcomes on the following: OS (secondary endpoint for Phase 2), PFS (secondary endpoint for Phase 3), OS for EGFRvIII mutated tumor sub-group, PFS for EGFRvIII mutated sub-group, time to deterioration in neurocognitive functioning, time to deterioration in symptom severity and symptom interference scores of the MDASI-BT questionnaire.
    Determinar si la adición de ABT-414 al tratamiento concurrente con radioterapia y temozolomida mejora los resultados de los siguientes: SG (criterio secundario para la Fase 2), SSP (criterio secundario para la Fase 3), SG en el subgrupo para tumores con la mutación EGFRvIII, SSP en el subgrupo para tumores con la mutación EGFRvIII, tiempo hasta el deterioro de la función neurocognitiva, tiempo hasta el deterioro de intensidad de los síntomas y hasta el deterioro de la puntuación de interferencia de los síntomas del cuestionario MDASI-BT
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is a pharmacogenetic sub-study optional translational and genetic sub-study The sub-studies are included in the main protocol with additional consents required for participation in these sub-studies
    Existen subestudios opcionales farmacogenético translacional y genético. Los subestudios están incluidos en el protocolo principal con consentimientos adicionales requeridos para la participación en estos subestudios
    E.3Principal inclusion criteria
    1. de novo GBM tumors that test positive for EGFR amplification.
    2. Age ? 18 years.
    3. Karnofsky performance status ? 70 ? 14 days prior to randomization.
    4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
    5. Adequate bone marrow, renal, and hepatic function ? 21 days prior to randomization.
    1. Tumores GBM de novo que resultan positivos a amplificación de EGFR
    2. Edad ? 18 años
    3. Estado funcional de Karnofsky ? 70 en la evaluación efectuada en los 14 días previos a la aleatorización
    5. Presencia de una función medular, renal y hepática adecuada en los 21 días previos a la aleatorización
    E.4Principal exclusion criteria
    1. multifocal, recurrent or metatstatic GBM or gliomatosis cerebri.
    2. prior chemo therapy or radiosensitizer for cancer of the head and neck region.
    3. prior radiotherapy to the head or neck resulting in overlap of radiation fields.
    4. prior therapy for glioblastoma or other invasive malignancy.
    5. prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
    1. GBM multifocal, recidivante o metastásico, o gliomatosis cerebral
    2. Administración previa de quimioterapia o radiosensibilizadores por cánceres de la región de la cabeza y el cuello
    3. Radioterapia previa de la cabeza y el cuello con superposición de los campos de irradiación
    4. Cualquier tratamiento previo contra el glioblastoma u otra neoplasia maligna invasiva
    5. Tratamiento previo, concurrente o previsto con NovoTTF, tratamiento dirigido contra EGFR, bevacizumab, discos de Gliadel u otro tratamiento antineoplásico intratumoral o intracavitario
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2: PFS (as determined by RANO criteria). Phase 3: OS
    Fase 2: SSP (conforme a los criterios RANO). Fase 3: SG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Imaging to determine PFS performed prior to initiation of adjuvant TMZ and then every 8 weeks thereafter.
    Pruebas de imagen para determinar SSP realizada previa al inicio de TMZ adyuvante y después cada 8 semanas
    E.5.2Secondary end point(s)
    OS (secondary endpoint for Phase 2), PFS (secondary endpoint for Phase 3), OS for EGFRvIII mutated tumor sub-group, PFS for EGFRvIII mutated sub-group, time to deterioration in Clinical Trial Battery composite score, time to deterioration in symptom severity score (MDASI-BT), time to deterioration on symptom interference score (MDASI-BT).
    SG (criterio secundario para la Fase 2), SSP (criterio secundario para la Fase 3), SG en el subgrupo para tumores con la mutación EGFRvIII, SSP en el subgrupo para tumores con la mutación EGFRvIII, tiempo hasta el deterioro de la puntuación de la batería para ensayos clínicos combinada, tiempo hasta el deterioro de la puntuación de intensidad de los síntomas (MDASI-BT), tiempo hasta el deterioro de la puntuación de interferencia de los síntomas (MDASI-BT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRIs will be performed evey other cycle, Clinical trial battery (COWA, HVLT-R, TMT-A&B) and MDASI-BT performed at screening, prior initiation of adjuvant TMZ, and every 8 weeks thereafter.
    Las RMs se realizarán cada ciclo alterno, la batería para ensayos clínicos (COWA, HVLT-R, TMT-A&B) y MDASI-BT realizados en selección, previo al inicio de TMZ adyuvante y después cada 8 semanas
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life assessments
    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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Colombia
    European Union
    Hong Kong
    Korea, Democratic People's Republic of
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Singapore
    South Africa
    Switzerland
    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
    Last Subject Last Visit
    Última Visita del Último Paciente
    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 months7
    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 months7
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 205
    F.4.2.2In the whole clinical trial 720
    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)
    ABT-414/placebo treatment in this study is added to standard background therapy (concomitant radiation therapy and temozolomide, followed by adjuvant temozolomide) per local institutional guidelines. ABT-414/placebo will be discontinued once disease progression has occurred, and subject will return to standard of care treatment per the investigator's discretion.
    El tratamiento con ABT-414/placebo en este estudio se añade a la terapia estándar de base (radioterapia concomitante y temozolomida, seguido de temozolomida adyuvante) según las directrices institucionales locales. ABT-414/placebo se suspenderá una vez que la enfermedad haya progresado, y el paciente volverá al tratamiento de cuidado habitual a discreción del investigador
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Radiation Therapy Oncology Group (RTOG)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-04
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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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