Continuation Study of the Oral AKT Inhibitor GSK2110183
20 de junho de 2019 atualizado 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.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
11
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Victoria
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Melbourne, Victoria, Austrália, 3004
- Novartis Investigative Site
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Ontario
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Toronto, Ontario, Canadá, M5G 1Z6
- Novartis Investigative Site
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Novartis Investigative Site
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New York
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New York, New York, Estados Unidos, 10029
- Novartis Investigative Site
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New York, New York, Estados Unidos, 10065
- Novartis Investigative Site
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Galway, Irlanda
- Novartis Investigative Site
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Seoul, Republica da Coréia, 110-744
- Novartis Investigative Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: GSK2110183 (afuresertib)
All patients received the GSK2110183 (afuresertib) treatment
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With at Least One Adverse Events (AEs)
Prazo: from the time of consent until the final study visit up to approx. 76 months
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Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
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from the time of consent until the final study visit up to approx. 76 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de fevereiro de 2012
Conclusão Primária (Real)
20 de junho de 2018
Conclusão do estudo (Real)
20 de junho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
9 de fevereiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de fevereiro de 2012
Primeira postagem (Estimativa)
13 de fevereiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de junho de 2019
Última verificação
1 de junho de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 115131
- 2014-002041-22 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .