Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
8 de setembro de 2016 atualizado por: AstraZeneca
A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
In addition, the pharmacokinetic profile of AZD6244 will be investigated.
Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.
The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.
Tipo de estudo
Intervencional
Inscrição (Real)
33
Estágio
- Fase 1
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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Fukuoka-shi, Japão
- Research Site
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Kashiwa-shi, Japão
- Research Site
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Nagoya-shi, Japão
- Research 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
20 anos a 130 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
- Patients who have overall good general conditions.
- Patients who have at least one lesion that can be accurately assessed by imaging.
- Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
- Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
Exclusion Criteria:
- Patients with brain metastases or spinal cord compression.
- Patients with significant abnormal ECG findings.
- Patients with evidence of severe or uncontrolled systemic disease.
- The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
- Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.
Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.
Patients with histologically or cytologically confirmed advanced solid malignancies.
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: Selumetinib (AZD6244) 25 mg
monotherapy
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Tablet Oral bid
Outros nomes:
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Experimental: Selumetinib (AZD6244) 50 mg
monotherapy
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Tablet Oral bid
Outros nomes:
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Experimental: Selumetinib (AZD6244) 75 mg
monotherapy
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Tablet Oral bid
Outros nomes:
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Experimental: Selumetinib (AZD6244) 75 mg + Doce
Combination
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Tablet Oral bid
Outros nomes:
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Experimental: Selumetinib (AZD6244) 25 mg + Doce
combination
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Tablet Oral bid
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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Cmax of Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
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Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
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Tmax of Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
|
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
|
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AUC(0-12) of Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
|
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Cmax of N-desmethyl Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
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Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
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Tmax of N-desmethyl Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
|
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
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AUC(0-12) of N-desmethyl Selumetinib After Single Dose
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib
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Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
|
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Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
|
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
|
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AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Prazo: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
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Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
|
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
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Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Prazo: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
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Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yuichiro Ohe, Medical Doctor, National Cancer Centre East
- Investigador principal: Hideo Saka, Medical Doctor, National Hospital Organisation Nagoya Medical Centre
- Investigador principal: Takashi Seto, Medical Doctor, National Hospital Organization Kyushu Cancer Center
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
1 de junho de 2012
Conclusão Primária (Real)
1 de abril de 2015
Conclusão do estudo (Real)
1 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de maio de 2012
Primeira postagem (Estimativa)
25 de maio de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2016
Última verificação
1 de setembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D1532C00067
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