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A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

28 de febrero de 2019 actualizado por: Janssen Research & Development, LLC

A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Tipo de estudio

Intervencionista

Inscripción (Actual)

82

Fase

  • Fase 2

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

  • Corea, república de
      • Busan, Corea, república de
      • Cheongju-Si, Corea, república de
      • Seongnam-Si, Gyeonggi-Do, Corea, república de
      • Seoul, Corea, república de
  • Taiwán
      • Kaohsiung, Taiwán
      • Taichung, Taiwán
      • Taichung City, Taiwán
      • Taipei, Taiwán
      • Taoyuan County, Taiwán

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

Masculino

Descripción

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
  • Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
  • Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
  • Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
  • Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
  • Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Exclusion Criteria:

  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension
  • Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
  • Has abnormal liver function tests
  • Surgery or local prostatic intervention within 30 days of the first dose

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Abiraterone actetate and Prednisolone
Droga: Abiraterone acetate
Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
Otros nombres:
  • JNJ-212082
Droga: Prednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Prostate-specific Antigen (PSA) Response
Periodo de tiempo: Baseline, Month 4
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Baseline, Month 4

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: Up to 3 Years
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
Up to 3 Years
Time to PSA Progression
Periodo de tiempo: Up to 28 Months
Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
Up to 28 Months
Percentage of Participants With Objective Radiographic Response
Periodo de tiempo: Up to 3 Years
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Up to 3 Years
Serum Testosterone
Periodo de tiempo: Baseline and End-of-Treatment Visit (up to approximately 3 years)
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
Baseline and End-of-Treatment Visit (up to approximately 3 years)
Dehydroepiandrosterone Sulfate (DHEA-S)
Periodo de tiempo: Baseline and End-of-Treatment Visit (up to approximately 3 years)
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
Baseline and End-of-Treatment Visit (up to approximately 3 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to 3 Years
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to 3 Years

Colaboradores e Investigadores

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

Patrocinador

Janssen Research & Development, LLC

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)

30 de agosto de 2011

Finalización primaria (Actual)

24 de enero de 2013

Finalización del estudio (Actual)

6 de marzo de 2018

Fechas de registro del estudio

Enviado por primera vez

12 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2012

Publicado por primera vez (Estimar)

17 de septiembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de marzo de 2019

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

28 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR100009
  • 212082PCR2007 (Otro identificador: Janssen Research & Development, LLC)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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