Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003749-40
    Sponsor's Protocol Code Number:GO27878
    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:2014-12-22
    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 number2013-003749-40
    A.3Full title of the trial
    A Phase Ib/II, open label study evaluating the safety and pharmacokinetics of GDC-0199 (ABT-199) in combination with Rituximab (R) or Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B Cell non-hodgkin's lymphoma (NHL) and DLBCL
    ESTUDIO DE FASE IB/II, ABIERTO PARA EVALUAR LA SEGURIDAD Y LA FARMACOCINÉTICA DE GDC?0199 (ABT-199) EN COMBINACIÓN CON RITUXIMAB (R) O OBINUTUZUMAB (G) MÁS CICLOFOSFAMIDA, DOXORRUBICINA, VINCRISTINA Y PREDNISONA (CHOP) EN PACIENTES CON LINFOMA NO HODGKIN (LNH) DE CÉLULAS B Y LDCGB (Linfoma Difuso de Células Grandes B)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma
    ESTUDIO PARA EVALUAR LA SEGURIDAD Y LA FARMACOCINÉTICA DE GDC?0199 EN PACIENTES CON LINFOMA NO HODGKIN
    A.4.1Sponsor's protocol code numberGO27878
    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 SponsorRoche Farma, S.A. en nombre de F. Hoffmann- La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann- La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGDC-0199
    D.3.2Product code RO5537382
    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 INNGDC-0199
    D.3.9.2Current sponsor codeRO5537382
    D.3.9.3Other descriptive nameABT-199
    D.3.9.4EV Substance CodeSUB130380
    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 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.IMP: 2
    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/3/12/1054
    D.3 Description of the IMP
    D.3.1Product nameOBINUTUZUMAB
    D.3.2Product code RO5072759
    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 INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.9.3Other descriptive nameOBINUTUZUMAB
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 3
    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 Yes
    D.2.1.1.1Trade name Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.2Product code Ro0452294
    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 INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    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.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
    B-cell non-hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL)
    LINFOMA NO HODGKIN (LNH) DE LINFOMAS B Y LMDLB
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin's Lymphoma
    Linfoma no Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10029601
    E.1.2Term Non-Hodgkin's lymphoma refractory
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10029600
    E.1.2Term Non-Hodgkin's lymphoma recurrent
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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 the Phase I portion of the study is:
    ? To estimate the maximum tolerated dosing schedule for GDC-0199 given in combination with R-CHOP or G-CHOP to patients with B-cell NHL, either previously untreated or relapsed/refractory after a maximum of one prior therapy
    The primary objectives of the Phase II portion of the study are:
    ? To assess the safety and tolerability of the combination of GDC-0199 and R-CHOP or G-CHOP administered to patients with previously untreated DLBCL
    ? To make a preliminary assessment of efficacy as measured by CR rate determined by PET/CT scan (see Appendix 2), of the combination of GDC-0199 and R-CHOP administered to patients with previously untreated DLBCL
    El objetivo principal de la parte de fase I del estudio es:
    ?Calcular la pauta posológica máxima tolerada para GDC-0199 administrado en combinación con R-CHOP o G-CHOP en pacientes con linfoma no Hodgkin (LNH) de linfocitos B, ya hubieran sido tratados previamente o sean recidivantes/resistentes tras un máximo de un tratamiento anterior
    Los objetivos principales de la parte de fase II del estudio son:
    ?Evaluar la seguridad y la tolerabilidad de la combinación de GDC-0199 más R-CHOP o G CHOP administrado en pacientes con linfoma macrocítico difuso de linfocitos B (LMDLB) sin tratamiento previo
    ?Realizar una evaluación preliminar de la eficacia medida por la tasa de respuesta completa (RC) determinada mediante exploración por tomografía por emisión de positrones/tomografía computarizada (TEP/TAC) de la combinación de GDC-0199 y R-CHOP administrado a pacientes con LMDLB no tratado previamente
    E.2.2Secondary objectives of the trial
    The PK objectives of this study are:
    ? To characterize the PK of GDC-0199 when administered in combination with R-CHOP or G-CHOP in the relapsed/refractory or previously untreated setting
    ? To characterize the PK of rituximab, obinutuzumab, and CHOP components when administered in combination with GDC-0199 in relapsed/refractory or previously untreated B-cell NHL
    The activity objective of this study includes:
    ? To make a preliminary assessment of efficacy when GDC-0199 and R-CHOP are administered in combination to patients with previously untreated DLBCL, as measured by:
    ? OR rate
    ? CR rate as determined by CT scan
    ? Response duration
    ? PFS
    ? OS
    ? To make a preliminary assessment of efficacy when GDC-0199 and G-CHOP are administered in combination, as measured by OR, CR and PFS.

    Please see section 2.2.3 of the protocol for additional explotatory objectives
    Los objetivos farmacocinéticos de este estudio son:
    ?Caracterizar la farmacocinética de GDC-0199 cuando se administra en combinación con R-CHOP o G-CHOP en contexto recidivante/resistente o sin tratamiento previo
    ?Caracterizar la farmacocinética de rituximab, obinutuzumab y los componentes de CHOP cuando se administra en combinación con GDC-0199 en LNH de linfocitos B recidivante/resistente o sin tratamiento previo
    Los objetivos secundarios para este estudio son:
    ?Realizar una evaluación preliminar de la eficacia cuando GDC-0199 y R-CHOP se administran en combinación a pacientes con LMDLB sin tratamiento previo, medida por:
    - Tasa de respuesta objetiva (RO)
    - Tasa de RC determinada por TAC
    - Duración de la respuesta
    - SSP
    - SG
    ?Realizar una evaluación preliminar de la eficacia cuando GDC-0199 y G-CHOP se administran en combinación, medida por la tasa de RO, la tasa de RC y la tasa de SSP
    Por favor, ver sección 2.2.3 del protocol para objtivos exploratorios adicionales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria:
    - Patients, age >= 18 years
    - At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its longest dimension
    - Ability and willingness to comply with the study protocol procedures
    - Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
    - ECOG performance status of 0, 1, or 2
    - Adequate hematologic function
    - For female patients of childbearing potential and male patients with female partners of childbearing potential, agreement to use highly effective forms of contraception

    Dose Escalation Portion of the Study:
    - Patients must have histologically confirmed B-cell non- Lymphoma (NHL)
    - Patients must have never received previous R-CHOP treatment
    - Any relapsed/refractory patients that are enrolled during the dose escalation should have received only a single previous treatment regimen

    Expansion Portion of the Study:
    - Patients must have previously-untreated diffuse large, B-cell lymphoma
    - International prognostic index (IPI) score must be 2-5
    Criterios de inclusión generales:
    ?Edad >= 18 años
    ?Al menos una lesión medible bidimensionalmente en exploraciones por TAC definida como 1,5 cm en su dimensión más larga
    ?Capacidad y disposición para cumplir con los procedimientos del protocolo del estudio
    ?Disponibilidad confirmada de tejido tumoral de archivo o recientemente biopsiado que cumpla con las especificaciones definidas en el protocolo antes de la inscripción en el estudio
    ?Estado general de 0, 1 o 2 del Grupo oncológico cooperativo del este (Eastern Cooperative Oncology Group, ECOG)
    ?Función hematológica adecuada

    ?Los pacientes deben tener LNH de linfocitos B confirmado histológicamente
    ?Los pacientes nunca deben haber recibido previamente tratamiento con R-CHOP
    ?Cualquier paciente en recaída/refractario que se haya inscrito durante el incremento de dosis debe haber recibido solo una pauta de tratamiento previa única.
    ?Para mujeres potencialmente fértiles y hombre con parejas pontencialmente fértiles, acuerdo de usar métodos anticonceptivos altamente eficaces.
    Criterios de inclusión aplicables a pacientes inscritos en la parte de fase II del estudio:
    ?Los pacientes deben tener un LMDLB sin tratamiento previo
    ?La puntuación del IPI debe ser 2?5
    E.4Principal exclusion criteria
    General Exclusion Criteria:
    - Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
    - Primary CNS lymphoma
    - Vaccination with live vaccines within 28 days prior to randomization
    - History of other malignancy that could affect compliance with the protocol or interpretation of results
    - Evidence of significant, concomitant disease or illness
    - Use of CYP3A inhibitors or inducers within 7 days of the first dose of GDC-0199
    - Requires use of Warfarin
    - Recent major surgery
    - Women must not be pregnant or breastfeeding

    Dose Escalation Portion of the Study:
    - Prior anthracycline therapy
    - Chemotherapy or other investigational therapy within 5 half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
    - histologically confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)

    Expansion Portion of the Study:
    - Patients with transformed lymphoma
    - Prior therapy for non-hodgkin's lymphoma (NHL)
    - Current Grade > 1 peripheral neuropathy
    Criterios de exclusión generales:
    ?Contraindicación para recibir cualquiera de los componentes individuales de CHOP, rituximab u obinutuzumab
    ?Linfoma principal del SNC
    ?Vacunación con vacunas inactivadas dentro de los 28 días previos al tratamiento
    ?Antecedentes de otra neoplasia maligna que pudiera afectar al cumplimiento del protocolo o la interpretación de los resultados
    ?Evidencia de enfermedades concomitantes, significativas y no controladas
    ? Ha recibido Inhibidores del CYP3Al en el plazo de 7 días antes de la primera dosis de GDC-0199
    ?Requiere el uso de warfarina
    ?Cirugía mayor reciente
    ?Mujeres embarazadas o en período de lactancia
    Parte de búsqueda de la dosis del estudio:
    ?Tratamiento previo con antraciclina
    ?Quimioterapia u otro tratamiento en investigación dentro de los 5 semividas de un agente biológico con un mínimo de 28 días antes del inicio del ciclo 1
    Histológicamente confirmado linfoma del manto (LM) o linfoma linfocítico de células pequeñas (LLP)
    Parte de fase II del estudio:
    ?Pacientes con linfoma transformado
    ?Tratamiento anterior para el LNH
    ? Neuropatía periférica de grado > 1 actual
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety: Incidence of dose-limiting toxicities
    2. Complete response (CR) defined by PET/CT scan and bone marrow examination
    1. Seguridad: Incidencia de la toxicidad limitante de la dosis
    2. RC, definido mediante exploración TEP/TAC así como exploración de la médula ósea
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Approximately 9 months
    2. Approximately 9 months
    1. Aproximadamente 9 meses
    2. Aproximadamente 9 meses
    E.5.2Secondary end point(s)
    1. Pharmacokinetics: plasma concentration-time profile of GDC-0199
    2. Objective response (partial or complete response) rate
    3. Response duration, defined as time from first documented response until relapse or death
    4. Incidence of adverse events
    5. Progression-free survival
    6. Overall survival
    7. CR defined by CT scan and bone marrow examination
    8. Relative dose intensity
    1. Farmacocinéticos: se derivará del perfil de concentración plasmática con el tiempo de GDC-0199
    2. Tasa de respuesta objetiva (RO)
    3. DR, que se define como la primera aparición de una respuesta documentada y objetiva hasta el momento de la recaída o muerte
    4. Incidencia de efectos adversos
    5. Supervivencia sin progresión
    6. Supervivencia general
    7. RC, definido mediante exploración por TAC y exploración de médula ósea
    8. Intensidad de la dosis relativa
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Approximately 9 months
    2. Approximately 9 months
    3. Approximately 1 year
    4. Approximately 1 year
    5. Approximately 1 year
    6. Approximately 1 year
    7. Approximately 9 months
    8. Approximately 9 months
    1. Aproximadamente 9 months
    2. Aproximadamente 9 months
    3. Aproximadamente 1 year
    4. Aproximadamente 1 year
    5. Aproximadamente 1 year
    6. Aproximadamente 1 year
    7. Aproximadamente 9 months
    8. Approximately 9 months
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding study
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Canada
    Czech Republic
    France
    Hungary
    Italy
    Netherlands
    Spain
    United States
    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 study will be defined as one year following initiation of treatment of the last patient enrolled
    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 months2
    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 months9
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    Continued access to GDC-0199, CHOP, rituximab and/or obinutuzumab is not guaranteed after the end of the study. After the patient?s participation in the study ends, the patient or the patient?s health plan will need to pay for medicines and clinic, hospital, and doctors? services that are part of the patient?s regular medical care.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 14:32:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA