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    Summary
    EudraCT Number:2014-000726-37
    Sponsor's Protocol Code Number:CINC280X2105C
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-10-03
    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 number2014-000726-37
    A.3Full title of the trial
    A phase Ib/II, multicenter, open-label study of EGF816 in combination with INC280 in adult patients with EGFR mutated non-small cell lung cancer
    Estudio fase Ib/II, multicéntrico, abierto de EGF816 en combinación con INC280 en pacientes adultos con cáncer de pulmón de células no pequeñas EGFR mutado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and efficacy of EGF816 in combination with INC280 in non-small cell lung cancer patients with EGFR mutation
    Estudio de seguridad y de eficacia de EGF816 en combinación con INC280 en pacientes con cáncer de pulmón de células no pequeñas con EGFR mutado
    A.4.1Sponsor's protocol code numberCINC280X2105C
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 INC280
    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 INNINC280
    D.3.9.1CAS number 1197376-85-4
    D.3.9.2Current sponsor codeINC280
    D.3.9.3Other descriptive nameINC280
    D.3.9.4EV Substance CodeSUB31645
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code INC280
    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 INNINC280
    D.3.9.1CAS number 1197376-85-4
    D.3.9.2Current sponsor codeINC280
    D.3.9.3Other descriptive nameINC280
    D.3.9.4EV Substance CodeSUB31645
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 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 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 EGF816
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEGF816
    D.3.9.1CAS number EGF816
    D.3.9.2Current sponsor codeEGF816
    D.3.9.3Other descriptive nameEGF816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 4
    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 EGF816
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEGF816
    D.3.9.1CAS number EGF816
    D.3.9.2Current sponsor codeEGF816
    D.3.9.3Other descriptive nameEGF816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 5
    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 EGF816
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEGF816
    D.3.9.1CAS number EGF816
    D.3.9.2Current sponsor codeEGF816
    D.3.9.3Other descriptive nameEGF816
    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.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
    non-small cell lung cancer
    cáncer de pulmón de células no pequeñas
    E.1.1.1Medical condition in easily understood language
    non-small cell lung cancer
    cáncer de pulmón de células no pequeñas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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
    Phase Ib part: To estimate the MTD or RP2D of EGF816 in combination with INC280
    Phase II part: To estimate the preliminary anti-tumor activity of EGF816 in combination with INC280
    Parte de la fase Ib: Calcular la DMT o DRF2 de EGF816 en combinación con INC280
    Parte de la fase II: Calcular la actividad antitumoral preliminar de EGF816 en combinación con INC280
    E.2.2Secondary objectives of the trial
    To characterize the safety, tolerability and pharmacokinetics of EGF816 in combination with INC280
    To evaluate the preliminary anti-tumor activity of EGF816 in combination with INC280
    Caracterizar la seguridad, tolerabilidad y farmacocinética de EGF816 en combinación con INC280
    Evaluar la actividad antitumoral preliminar de EGF816 en combinación con INC280
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Patients (male or female) ? 18 years of age.
    ? Patients with histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer.
    ? Patients must have EGFR mutation L858R and/or ex19del.
    ? Presence of at least one measurable lesion according to RECIST v.1.1
    ? ECOG performance status ?2
    ? Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g. erlotinib, gefitinib or afatinib, other EGFR TKIs may be allowed after discussion with Novartis).
    ? Phase II Group 1 only: Patients with acquired resistance to EGFR TKI treatment defined as documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI therapy (e.g. erlotinib, gefitinib or afatinib, other EGFR TKIs may be allowed after discussion with Novartis) who subsequently demonstrated progression according to RECIST v1.1.
    ? Phase II Group 2 only: Advanced NSCLC patients who have not been previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation
    ? Pacientes (hombres o mujeres) ? 18 años de edad
    ? Pacientes con cáncer de pulmón de células no pequeñas localmente avanzado o recurrente (estadío IIIB que no sea apto para el tratamiento de modalidad combinada) o metastásico (estadío IV), histológicamente documentado.
    ? Pacientes con mutación en el EGFR L858R y/o ex19del
    ? Presencia de por lo menos una lesión medible según los RECIST v1.1, según el Suplemento 1.
    ? Estado funcional del ECOG ? 2
    ? Sólo fase Ib: progresión documentada de enfermedad según los RECIST v1.1 mientras recibían tratamiento continuo con TKI del EGFR (por ejemplo, erlotinib, gefitinib o afatinib, otros TKIs del EGFR pueden permitirse tras discusión con Novartis).
    ? Sólo grupo 1 de la fase II: Pacientes con resistencia adquirida al tratamiento con TKI del EGFR, definida como beneficio clínico documentado (RC (cualquier duración), RP (cualquier duración) o EE durante por lo menos 6 meses) con terapia previa con TKI del EGFR (por ejemplo, erlotinib, gefitinib o afatinib, pueden permitirse otros TKIs del EGFR tras discusión con Novartis) que posteriormente demostraron progresión según los RECIST v.1.1.
    ? Sólo grupo 2 de la fase II: Pacientes con CPCNP avanzado que no hayan sido tratados previamente con ninguna terapia que se conozca que inhibe el EGFR y portadores de mutación T790M de novo.
    E.4Principal exclusion criteria
    ? Phase Ib and Phase II Group 1 only: Patients who have received more than one prior line of EGFR TKI therapy
    ? Phase Ib and Phase II Group 1 only: Patients who have received more than three prior lines of antineoplastic therapy (including EGFR TKI) in the advanced setting.
    ? Phase II Group 2 only: Patients who have received more than two previous lines of antineoplastic therapies in advance setting.
    ? Phase II Group 2 only: Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors.
    ? Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
    ? Patients with brain metastases.
    ? Patients have out of range laboratory values defined as
    ? Absolute Neutrophil Count (ANC) <1.5 x 109/L
    ? Hemoglobin (Hb) <9 g/dL
    ? Platelets (PLT) <100 x 109/L
    ? Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert?s syndrome total bilirubin >2.5 x ULN.
    ? AST and/or ALT >3 x ULN
    ? Patients with tumor involvement of the liver must have AST and/or ALT >5 x ULN
    ? Serum creatinine >1.5 x ULN
    ? Measured or calculated creatinine clearance ?45mL/min
    ? Asymptomatic serum amylase and lipase > Grade 2
    ? Serum amylase or serum lipase CTCAE grade ? 1 with signs and/or symptoms suggesting pancreatitis or pancreatic injury
    ? Sólo fase Ib y grupo 1 de la fase II: Pacientes que hayan recibido más de una línea previa de terapia con TKI del EGFR
    ? Sólo fase Ib y grupo 1 de la fase II: Pacientes que hayan recibido más de tres líneas previas de terapia antineoplásica (incluyendo TKI del EGFR) en el marco avanzado.
    ? Sólo grupo 2 de la fase II: Pacientes que hayan recibido más de dos líneas previas de terapias antineoplásicas en el marco avanzado.
    ? Sólo grupo 2 de la fase II: Tratamiento previo con un agente en investigación o comercializado que inhiba el EGFR. Los inhibidores del EGFR incluyen (pero no están limitados a) erlotinib, gefitinib u otro anticuerpo monoclonal anti-EGFR o EGF o terapia de anticuerpo monoclonal o inhibidores de TKI duales.
    ? Tratamiento previo con un inhibidor de c-MET o con terapia dirigida al HGF.
    - Pacientes con metástasis cerebrales.
    - Pacientes que presenten valores fuera del intervalo de laboratorio, definido como:
    - Recuento absoluto de neutrófilos (RAN) <1.5 x 109/L
    - Hemoglobina (Hgb) < 9 g/dL
    - Plaquetas (PLT) <100 x 109/L
    - Bilirrubina total > 1.5 x límite superior de normalidad (LSN). Para pacientes con síndrome de Gilbert, bilirrubina total > 2.5 x LSN.
    - AST y/o ALT > 3 x LSN.
    - Los pacientes con afectación tumoral hepática deberán presentar AST y/o ALT > 5 x LSN
    - Creatinina sérica > 1.5 x LSN
    - Aclaramiento de creatinina medido o calculado ? 45 mL/min
    - Amilasa y lipasa sérica asintomática > grado 2
    - Amilasa sérica o lipasa sérica de grado ? 1 de los CTCAE con signos y/o síntomas que sugieran pancreatitis o lesión pancreática
    E.5 End points
    E.5.1Primary end point(s)
    1-Phase Ib part: Incidence of DLTs
    2-Phase II part: Objective response rate (ORR) per RECIST v1.1
    1-Fase Ib parte: Incidencia de TLD
    2-Fase II parte: tasa de respuesta objetiva (ORR) por RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-First 28 days of treatment
    2-Baseline, every 12 weeks
    1-Primeros 28 días de tratamiento
    2-Desde el inicio, cada 12 semanas
    E.5.2Secondary end point(s)
    Phase Ib/II parts:
    1-Safety: AEs and SAEs
    2-0Safety: hematology and chemistry values, vital signs and ECGs
    3-Tolerability: Dose interruptions, reductions and dose intensity

    Phase Ib part:
    4- ORR, disease control rate (DCR),
    5- PFS, duration of response
    6- overall survival (OS)
    Phase II part:
    7-DCR
    8- PFS duration of response
    9- OS
    Phase Ib/II parts:
    10-Plasma concentration vs time profiles.
    Plasma PK parameters of EGF816 and INC280
    Fase partes Ib / II:
    1-Seguridad: AES y SAEs
    2-Seguridad: valores hematológicos y de química, signos vitales y ECG
    3-Tolerabilidad: interrupciones, reducciones de dosis y dosis de intensidad

    Fase Ib parte:
    4-ORR, tasa de control de la enfermedad (DCR),
    5- PFS, duración de la respuesta
    6- supervivencia global (OS)
    Fase II parte:
    7-DCR
    8- PFS, Duración de respuesta
    9- OS
    Fase partes Ib / II:
    10- Concentración de plasma vs perfiles de tiempo.
    Parámetros de PK de plasma de EGF816 y INC280
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase Ib/II parts:
    1-From baseline until 30 days post study treatment
    2-From baseline until end of treatment
    3-From start of treatment until end of treatment

    Phase Ib part:
    4-Baseline, every 12 weeks
    5-Start of treatment, every 12 weeks
    6-Start of treatment until death, average 9 months

    Phase II part:
    7-Baseline, every 12 weeks
    8-Start of treatment, every 12 weeks
    9-Start of treatment until death, average 9 months
    Phase Ib/II parts:
    10-First 4 cycles
    Phase Ib : full PK on Days 1, 2, 15 and 16 of Cycle 1, and Days 1 and 2 of Cycle 2, & Pre-dose blood PK samples will be collected on Day 8 of Cycle 1, Day 1 of Cycle 3 and Cycle 4
    Phase II: full PK on Days 1, and 2 of Cycle 1 and Cycle 2 & pre-dose PK on Day 8 of Cycle 1, Day 1 of Cycle 3 and Cycle 4
    Fase Ib/II:1-Desde inicio hasta 30 días después del tratamiento del estudio,2-Desde inicio hasta fin del tratamiento,3 Desde inicio del tratamiento hasta fin del mismo
    Fase Ib: 4-Desde inicio,cada 12 semanas,5-Inicio de tratamiento,cada 12 semanas ,6-inicio de tratamiento hasta muerte,promedio 9meses
    Fase II:7-Desde inicio,cada 12 semanas,8-Inicio de tratamiento,cada 12 semanas,9-inicio de tratamiento hasta muerte,promedio 9meses
    Fase Ib/II:10-Los primeros 4ciclos
    Fase Ib:PK completo en los días 1,2,15 y 16 del ciclo 1,y los días 1 y 2 de ciclo 2,& Pre-dosis muestras PK sangre será recogida en el día 8 de ciclo 1,el día 1 del ciclo 3 y ciclo 4
    Fase II:PK completo en los días 1 y 2 de los ciclos 1 y 2 y antes de la dosis de PK en el día 8 de ciclo 1,el día 1 del ciclo 3 y 4 del ciclo
    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 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) 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
    Phase Ib/ II
    Fase Ib/II
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Norway
    Singapore
    Spain
    Taiwan
    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
    End of study will be upon completion of the follow up period of the last patient treated with EGF816 and INC280, or when the study is terminated early.
    Completion of the FU period is defined as once all patients have discontinued study treatment and have either been followed up for survival for at least 9 months after the start of study treatment, died or have been lost to follow up, whichever occurs first.
    El final del estudio tendrá lugar cuando finalice el periodo de FU del último paciente tratado con la combinación de EGF816 e INC280, o cuando el estudio finalice prematuramente.
    La finalización del periodo de FU se define cuando todos los pacientes hayan suspendido el tratamiento del estudio y se les haya controlado la supervivencia durante por lo menos 9 meses después del inicio del tratamiento del estudio, hayan muerto o se les haya perdido el seguimiento, lo que ocurra primero
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 78
    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)
    None
    Ninguno
    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 Decision2014-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-11
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