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- Ensaio Clínico NCT02285361
GIOTRIF rPMS in Korean Patients With NSCLC
A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
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Multiple Locations, Republica da Coréia
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion criteria:
- Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
- Age = 19 years at enrolment
- Patients who have signed on the data release consent form
Exclusion criteria:
- Known hypersensitivity to afatinib or any of its excipients
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients for whom GIOTRIF® is contraindicated according to the local label
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
GIOTRIF
|
NSCLC with GIOTRIF 20mg
NSCLC with GIOTRIF 40mg
NSCLC with GIOTRIF 30mg
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Participants With Adverse Drug Reactions (ADRs)
Prazo: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Percentage of participants with Adverse Drug Reactions (ADRs).
|
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression-Free Survival (PFS) Rate at 48 Weeks
Prazo: From week 0 until week 48. Up to 48 weeks.
|
Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve. |
From week 0 until week 48. Up to 48 weeks.
|
Percentage of Participants With Best Response
Prazo: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
|
Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site. Tumour response according to investigator's assessment Each patient will be assigned to one of the following categories:
|
Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
|
Overall Survival (OS)
Prazo: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS. For patients with known date of death: OS [days] = date of death - (date of start of treatment) + 1 For patients known not death case: OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1. |
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1200.235
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 .
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