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    Summary
    EudraCT Number:2018-000635-27
    Sponsor's Protocol Code Number:2002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000635-27
    A.3Full title of the trial
    Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
    Brigatinib en pacientes con cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+) cuyo cáncer ha progresado durante el tratamiento con alectinib o ceritinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
    Brigatinib en pacientes con cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+) cuyo cáncer ha progresado durante el tratamiento con alectinib o ceritinib
    A.4.1Sponsor's protocol code number2002
    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 SponsorARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportARIAD Pharmaceuticals, Inc.(a wholly-owned subsidiary of Takeda Pharmaceutical Ltd.)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceuticals Inc.
    B.5.2Functional name of contact pointAshwata Pokhrel
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number900 811 335
    B.5.5Fax number+1617551 3742
    B.5.6E-mailashwata.pokhrel@takeda.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 nameBrigatinib
    D.3.2Product code AP26133
    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 INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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.3.1Product nameBrigatinib
    D.3.2Product code AP26133
    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 INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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.3.1Product nameBrigatinib
    D.3.2Product code AP26133
    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 INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC)
    Cáncer de pulmón de células no pequeñas avanzado con linfoma anaplásico cinásico positivo (ALK+)
    E.1.1.1Medical condition in easily understood language
    Metastatic or locally advanced non-small cell lung cancer
    Cáncer de pulmón de células no pequeñas metastático o localmente avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib as determined by investigator.
    Determinar la eficacia de brigatinib, demostrada mediante la tasa de respuesta objetiva (TRO) confirmada, en pacientes con CPCNP ALK+, localmente avanzado o metastásico, cuya enfermedad ha progresado durante el tratamiento con alectinib o ceritinib, según la determinación del investigador.
    E.2.2Secondary objectives of the trial
    1. To characterize the durability of efficacy with brigatinib.
    2. To assess intracranial efficacy of brigatinib.
    3. To assess the overall survival (OS).
    4. To assess the safety and tolerability of brigatinib.
    5. To collect plasma concentration-time data for brigatinib to contribute to population pharmacokinetic analyses.
    6. To assess patient-reported symptoms and health-related quality of life (HRQOL).
    1. Caracterizar la durabilidad de la eficacia con brigatinib.
    2. Evaluar la eficacia intracraneal de brigatinib.
    3. Evaluar la supervivencia global (SG).
    4. Evaluar la seguridad y tolerabilidad de brigatinib.
    5. Recopilar datos de concentración plasmática frente al tiempo de brigatinib para contribuir a los análisis de farmacocinética poblacional.
    6. Evaluar los síntomas notificados por el paciente y la calidad de vida relacionada con la salud (CdVRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non–small-cell lung cancer (NSCLC).
    2. Must meet both of the following 2 criteria:
    a. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non–FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
    b. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
    3. Had progressive disease (PD) while on alectinib or ceritinib
    4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
    5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
    6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade =1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
    7. Have a life expectancy of ≥3 months.
    1. Tener CPCNP en estadio IIIB (localmente avanzado o recurrente y que no sea candidato a un tratamiento con intención curativa) o estadio IV, confirmado mediante histología o citología.
    2. Debe cumplir los 2 criterios siguientes:
    a) Tener documentación del reordenamiento de ALK mediante un resultado positivo de cualquier prueba de laboratorio aprobada por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) o tener reordenamiento de ALK documentado mediante una prueba diferente (pruebas del laboratorio local no aprobadas por la FDA) y ha proporcionado muestra tumoral al laboratorio central. (Nota: no es necesario obtener los resultados del análisis de reordenamiento de ALK del laboratorio central antes de la aleatorización).
    b) El paciente había recibido tratamiento con uno de los inhibidores de la tirosina quinasa ALK (TKI) (alectinib, ceritinib, crizotinib) durante al menos 12 semanas antes de la progresión.
    3. Presentó progresión de la enfermedad mientras recibía alectinib o ceritinib.
    4. Recibió alectinib o ceritinib como el tratamiento inhibidor de ALK más reciente.
    5. Tiene al menos 1 lesión medible según RECIST versión 1.1, evaluada por el investigador.
    6. Se ha recuperado de las toxicidades relacionadas con el tratamiento antineoplásico previo, según los Criterios terminológicos comunes para acontecimientos adversos del Instituto Nacional del Cáncer, versión 4.03, Grado =1. (Nota: la alopecia o la neuropatía periférica relacionadas con el tratamiento que sean de un grado >1 se permiten si se consideran irreversibles) y tiene una función adecuada de los órganos principales.
    7. Tiene una esperanza de vida ≥ 3 meses.
    E.4Principal exclusion criteria
    1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
    2. Had received both alectinib and ceritinib.
    3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
    4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
    5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
    6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
    7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
    8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.
    1. Ha recibido algún TKI previo dirigido contra ALK que no sea crizotinib, alectinib o ceritinib.
    2. Ha recibido tanto alectinib como ceritinib.
    3. Ha recibido anteriormente más de 3 pautas de tratamiento antineoplásico sistémico para la enfermedad localmente avanzada o metastásica.
    4. Tiene metástasis cerebral sintomática (parenquimatosa o leptomeníngea). Puede inscribirse a pacientes con metástasis cerebral asintomática o que tengan síntomas estables que no requieran un aumento de la dosis de corticosteroides para controlar los síntomas en los últimos 7 días antes de la primera dosis de brigatinib.
    5. Tiene compresión medular actual (sintomática o asintomática, detectada por imágenes radiográficas). Se permiten participantes con enfermedad leptomeníngea y sin compresión de la médula.
    6. Tuvo un accidente cerebrovascular o un ataque isquémico transitorio dentro de los 6 meses antes de la primera dosis de brigatinib.
    7. Tiene una infección activa o en curso, que incluye, entre otros, requisito de antibióticos por vía intravenosa.
    8. Síndrome de malabsorción u otra enfermedad gastrointestinal (GI) que podría afectar la absorción oral de brigatinib.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is confirmed ORR, as assessed by the IRC, per Response Evaluation Criteria in Solid Tumors
    (RECIST) version 1.1 in the full analysis set population.
    El criterio de valoración principal es la TRO confirmada, evaluada por el comité de revisión independiente (CRI), de acuerdo con los criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, en la población del grupo completo de análisis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall timeframe will be pending on final sample size.
    El periodo general dependerá del tamaño de muestra final.
    E.5.2Secondary end point(s)
    1. Confirmed ORR, as assessed by the investigator, per RECIST version 1.1.
    2. DOR as assessed by the investigator and IRC.
    3. PFS as assessed by the investigator and IRC.
    4. Disease control rate (DCR), defined as best overall response of complete response (CR), partial response (PR) or
    stable disease (SD) ≥6 weeks by RECIST version 1.1, as assessed by the investigator and IRC.
    5. Time to response as assessed by the investigator and IRC.
    6. Confirmed iORR in patients with brain metastases at baseline, as assessed by the IRC.
    7. Duration of intracranial response in patients with brain metastases at baseline, as assessed by the IRC.
    8. Intracranial progression-free survival (iPFS) in patients with brain metastases at baseline, as assessed by the IRC.
    9. OS.
    10. Safety/tolerability (CTCAE version 4.03).
    11. HRQOL assessed with the global health status/quality of life (QOL) and other function and symptom from EORTC QLQ-C30 (version 3.0), and EORTC QLQ-LC13.
    1. TRO confirmada, evaluada por el investigador de acuerdo con RECIST versión 1.1.
    2. Duración de la respuesta (DR) evaluada por el investigador y el CRI.
    3. Supervivencia libre de progresión (SLP) evaluada por el investigador y el CRI.
    4. Tasa de control de la enfermedad (TCE), definida como la mejor respuesta global de respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE) ≥6 semanas, según RECIST versión 1.1, evaluada por el investigador y el CRI.
    5. Tiempo hasta la respuesta evaluado por el investigador y el CRI.
    6. TRO intracraneal (TROi) confirmada en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
    7. Duración de la respuesta intracraneal en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
    8. Supervivencia libre de progresión intracraneal (SLPi) en pacientes con metástasis cerebrales al inicio, evaluada por el CRI.
    9. SG.
    10. Seguridad/tolerabilidad (CTCAE versión 4.03).
    11. La CdVRS se evaluará con el estado de salud/calidad de vida (CdV) a nivel global y otras funciones y síntomas del EORTC QLQ-C30 (versión 3.0) y EORTC QLQ-LC13.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall timeframe will be pending on final sample size.
    El periodo general dependerá del tamaño de muestra final.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To evaluate exploratory biomarkers
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Austria
    Canada
    China
    France
    Germany
    Hong Kong
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Spain
    Sweden
    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
    The study will end when either all patients die or 3 years have passed since the last patient started study treatment, whichever comes first.
    El estudio terminará cuando o bien todos los pacientes hayan fallecido o cuando hayan pasado 3 años desde que el primer paciente empezó el tratamiento del estudio, lo que suceda antes.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 103
    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)
    Patients will continue to be treated with brigatinib until they experience objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity. With medical monitor approval, treatment may be continued at 180 mg QD or may be escalated to 240 mg QD after initial progression if there is still potential for clinical benefit.
    Los pacientes seguirán recibiendo tratamiento con brigatinib hasta que experimenten una progresión objetiva de la enfermedad, evaluada por el investigador de acuerdo con RECIST versión 1.1, o una toxicidad intolerable. En caso de que potencialmente puedan seguir beneficiándose del tratamiento, tras la progresión inicial se puede continuar el tratamiento a 180 mg o se puede aumentar a 240 mg con aprobación del supervisor médico
    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 Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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