- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01183858
A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 13125
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Berlin, Alemania, 14165
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Essen, Alemania, 45122
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Gauting, Alemania, 82131
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Grosshansdorf, Alemania, 22927
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Hannover, Alemania, 30625
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Hannover, Alemania, 30659
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Immenhausen, Alemania, 34376
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Lostau, Alemania, 39291
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München, Alemania, 81925
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Nürnberg, Alemania, 90419
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Rheine, Alemania, 48431
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Villingen-Schwenningen, Alemania, 78052
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Wuerselen, Alemania, 52146
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Wuppertal, Alemania, 42283
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Hillerod, Dinamarca, 3400
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København, Dinamarca, 2100
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Naestved, Dinamarca, 4700
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Roskilde, Dinamarca, 4000
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Cairo, Egipto, 11796
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Cairo, Egipto
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Barcelona, España, 08035
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Barcelona, España, 08041
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Madrid, España, 28040
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Madrid, España, 28041
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Malaga, España, 29010
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Sevilla, España, 41013
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Valencia, España, 46009
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Barcelona
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Sabadell, Barcelona, Barcelona, España, 08208
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Caen, Francia, 14076
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Limoges, Francia, 87042
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Marseille, Francia, 13915
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Paris, Francia, 75014
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Paris, Francia, 75908
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Paris, Francia, 75674
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Pontoise, Francia, 95300
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Ankara, Pavo, 06200
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Ankara, Pavo, 06000
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Eskisehir, Pavo, 26480
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Gaziantep, Pavo, 27310
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Izmir, Pavo, 35340
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Izmir, Pavo, 35110
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Konya, Pavo, 42050
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Amsterdam, Países Bajos, 1007 MB
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Breda, Países Bajos, 4818 CK
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Nieuwegein, Países Bajos, 3435 CM
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Zwolle, Países Bajos, 8011 JW
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Beijing, Porcelana, 100071
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Changchun, Porcelana, 130012
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Chengdu, Porcelana, 610041
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Fuzhou, Porcelana, 350014
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Guangzhou, Porcelana, 510030
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Nanjing, Porcelana, 210009
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Nanning, Porcelana, 530021
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Shanghai, Porcelana, 200433
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Shanghai, Porcelana, 200030
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Shenyang, Porcelana, 110001
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Tianjin, Porcelana, 300060
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Wuhan, Porcelana, 430030
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Baden, Suiza, 5404
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Basel, Suiza, 4031
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Bern, Suiza, 3011
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Fribourg, Suiza, 1708
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients aged ≥18 years
- inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥12 weeks
- Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria:
- Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
- Radiotherapy within 28 days prior to enrollment
- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
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Single daily oral dose
Otros nombres:
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Experimental: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
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Single daily oral dose
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-Free Survival (PFS)
Periodo de tiempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
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PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
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Progression-Free Survival (PFS) at the End of Study
Periodo de tiempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Survival (OS)
Periodo de tiempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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OS defined as the time from randomization to the date of death due to any cause.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Overall Response Rate (ORR)
Periodo de tiempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response).
Patients with no tumor assessment after the start of study treatment were to be considered as non-responders.
The percentage of participants in each best response category is presented.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Disease Control Rate (DCR)
Periodo de tiempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans.
Disease control rates were measured according to RECIST version 1.1 criteria.
A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks.
Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease.
The percentage of participants with Disease Control is presented.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Time to Progression (TTP)
Periodo de tiempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression.
Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Number of Participants With Adverse Events (AEs) at the End of the Study
Periodo de tiempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death. |
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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Overall Survival (OS) at the End of Study
Periodo de tiempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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OS defined as the time from randomization to the date of death due to any cause.
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Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Clorhidrato de erlotinib
Otros números de identificación del estudio
- MO22162
- 2010-018476-24 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de pulmón de células no pequeñas
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Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos
Ensayos clínicos sobre Erlotinib [Tarceva]
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National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern California y otros colaboradoresTerminadoCarcinoma de pulmón de células no pequeñasEstados Unidos
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Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.TerminadoCáncer de pulmón de células no pequeñas metastásico | Cáncer de pulmón de células no pequeñas recurrenteEstados Unidos
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PfizerTerminadoCarcinoma de pulmón de células no pequeñasEstados Unidos
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New Mexico Cancer Care AllianceTerminadoUn protocolo de fase 1 de 5-azacitidina y erlotinib en tumores malignos de tumores sólidos avanzadosNeoplasias malignas de tumores sólidos avanzadosEstados Unidos
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M.D. Anderson Cancer CenterTerminadoCánceres avanzadosEstados Unidos
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Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.TerminadoCarcinoma de pulmón de células no pequeñasEstados Unidos
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Merck Sharp & Dohme LLCTerminadoCarcinoma de pulmón de células no pequeñas
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Tragara Pharmaceuticals, Inc.TerminadoCáncer de pulmón de células no pequeñas recidivanteEstados Unidos
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University of ChicagoNational Cancer Institute (NCI)TerminadoMesotelioma Peritoneal MalignoEstados Unidos
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PfizerTerminadoCáncer de pulmón de células no pequeñasEstados Unidos, Corea, república de, Reino Unido, Grecia, Eslovaquia, Francia, Bélgica, Irlanda, Japón, España, Porcelana, Suecia, India, Hungría, Suiza, Federación Rusa, Alemania, México, Dinamarca, Austria, Finlandia, Polonia, Sudáfrica