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Continuation Study of the Oral AKT Inhibitor GSK2110183

20 de junio de 2019 actualizado por: Novartis Pharmaceuticals

An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies

This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

11

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

    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canadá, M5G 1Z6
        • Novartis Investigative Site
      • Seoul, Corea, república de, 110-744
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21231
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Novartis Investigative Site
    • New York
      • New York, New York, Estados Unidos, 10029
        • Novartis Investigative Site
      • New York, New York, Estados Unidos, 10065
        • Novartis Investigative Site
      • Galway, Irlanda
        • Novartis Investigative 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 a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Has provided signed informed consent for this study.
  • Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
  • Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen.
  • Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
  • Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183.
  • Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183.
  • Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
  • Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale
  • Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.
  • Have adequate organ system function

Exclusion Criteria:

  • Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression.
  • Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
  • Local access to commercially available GSK2110183.
  • Current use of a prohibitive medication(s)
  • Current use of anticoagulants
  • Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.
  • History of HIV infection.
  • Peripheral neuropathy greater than Grade 1
  • History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted).
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease).
  • QTcF interval greater than 500 msecs at the time of transition to this study.
  • Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
  • Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study.
  • Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study.
  • Lactating female or female who becomes pregnant prior to transition to this study.
  • Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.

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: GSK2110183 (afuresertib)
All patients received the GSK2110183 (afuresertib) treatment
Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
Otros nombres:
  • ASB183

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With at Least One Adverse Events (AEs)
Periodo de tiempo: from the time of consent until the final study visit up to approx. 76 months
Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
from the time of consent until the final study visit up to approx. 76 months

Colaboradores e Investigadores

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

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)

8 de febrero de 2012

Finalización primaria (Actual)

20 de junio de 2018

Finalización del estudio (Actual)

20 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de febrero de 2012

Primero enviado que cumplió con los criterios de control de calidad

9 de febrero de 2012

Publicado por primera vez (Estimar)

13 de febrero de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2019

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

20 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 115131
  • 2014-002041-22 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

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. .

Ensayos clínicos sobre Cáncer

Ensayos clínicos sobre GSK2110183 (afuresertib)

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