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A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

26 de junio de 2017 actualizado por: Hoffmann-La Roche

An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is <100 patients.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

132

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

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle; Melanoma Clinic
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital; Medical Oncology and Pallative Care
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter Maccallum Cancer Institute; Medical Oncology
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90095-6984
        • UCLA - School of Medicine; Division of Hematology/Oncology
    • Colorado
      • Denver, Colorado, Estados Unidos, 80262
        • University of Colorado
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Estados Unidos, 02115
        • Dana Farber Cancer Inst. ; Dept. of Medical Oncology
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital;Hematology/ Oncology
    • New York
      • New York, New York, Estados Unidos, 10036
        • New York University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
        • Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Texas Oncology-Baylor Sammons Cancer Center
      • Houston, Texas, Estados Unidos, 77030
        • University of Texas M.D. Anderson Cancer Center

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:

  • adult patients >/=18 years of age
  • histologically confirmed metastatic melanoma (Stage IV, AJCC)
  • patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
  • BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
  • measurable disease by RECIST criteria
  • negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

  • active CNS metastases on CT/MRI within 28 days prior to enrollment
  • history of or known carcinomatous meningitis
  • previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
  • cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential
  • uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy
  • infectious disease including HIV, HBV and HCV

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: Brazo único
Droga: vemurafenib
960 mg b.i.d. continuous oral dosing

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Periodo de tiempo: From first treatment through September 27, 2010
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
From first treatment through September 27, 2010

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Periodo de tiempo: From first treatment through September 27, 2010
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
From first treatment through September 27, 2010
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Periodo de tiempo: From first treatment through September 27, 2010
Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.
From first treatment through September 27, 2010
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Periodo de tiempo: From first treatment through September 27, 2010
Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.
From first treatment through September 27, 2010
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Periodo de tiempo: From first treatment through September 27, 2010
PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.
From first treatment through September 27, 2010
Overall Survival
Periodo de tiempo: From first treatment through September 27, 2010
Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.
From first treatment through September 27, 2010
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
Periodo de tiempo: From first treatment through September 27, 2010
Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.
From first treatment through September 27, 2010
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
Periodo de tiempo: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
Periodo de tiempo: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Levels at Various Treatment Cycles
Periodo de tiempo: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.
Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Periodo de tiempo: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.
Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Percentage of Patients With Adverse Event
Periodo de tiempo: From first treatment through September 27, 2010
The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).
From first treatment through September 27, 2010

Colaboradores e Investigadores

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

Patrocinador

Hoffmann-La Roche

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 septiembre de 2009

Finalización primaria (Actual)

27 de septiembre de 2010

Finalización del estudio (Actual)

3 de junio de 2014

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2009

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2009

Publicado por primera vez (Estimar)

30 de julio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de julio de 2017

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

26 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NP22657

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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