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Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

4 de diciembre de 2017 actualizado por: GlaxoSmithKline

A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)

This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

52

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Advanced solid tumors.
  • Able to swallow oral medication.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: All treated subjects
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
Droga: docetaxel
docetaxel
Droga: lapatinib
lapatinib

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of subjects with adverse events (AEs) or serious AEs (SAEs)
Periodo de tiempo: Up to 7 weeks in each cycle
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention will be categorized as SAE.
Up to 7 weeks in each cycle
Number of subjects with abnormal change from Baseline in laboratory parameters
Periodo de tiempo: Baseline and up to 7 weeks in each cycle
Blood sample will be collected to evaluate laboratory parameters.
Baseline and up to 7 weeks in each cycle
Number of subjects with Optimally Tolerated regimen
Periodo de tiempo: Up to 7 weeks in each cycle
Optimally Tolerated regimen is a dose regimen where 1 out of 6 subjects experiences a dose-limiting toxicity (DLT).
Up to 7 weeks in each cycle

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Cmax of GW572016 alone (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Cmax of GW572016 when given in combination with docetaxel (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
Cmax of GW572016 when given in combination with docetaxel (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Tmax of GW572016 alone (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Tmax of GW572016 when given in combination with docetaxel (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion.
Tmax of GW572016 when given in combination with docetaxel (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion
Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose.
AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Clearance (CL) for docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Elimination half-life (Thalf) for docetaxel alone (PK cohort 1)
Periodo de tiempo: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion.
Number of subjects with complete response
Periodo de tiempo: Week 3 of every third cycle
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
Week 3 of every third cycle
Number of subjects with partial response
Periodo de tiempo: Week 3 of every third cycle
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
Week 3 of every third cycle
Number of subjects with stable disease
Periodo de tiempo: Week 3 of every third cycle
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
Week 3 of every third cycle
Number of subjects with progressive disease
Periodo de tiempo: Week 3 of every third cycle
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
Week 3 of every third cycle

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de abril de 2003

Finalización primaria (Actual)

21 de enero de 2006

Finalización del estudio (Actual)

21 de enero de 2006

Fechas de registro del estudio

Enviado por primera vez

6 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

6 de septiembre de 2005

Publicado por primera vez (Estimar)

8 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de diciembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

4 de diciembre de 2017

Última verificación

1 de diciembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EGF10021

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. .

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