- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01953913
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
27 de junho de 2019 atualizado por: Boehringer Ingelheim
An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor).
Secondary objective is to assess the time to symptomatic progression (as judged by investigator).
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
542
Estágio
- Fase 3
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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Beijing, China, 100071
- 307 Hospital of PLA
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100853
- Chinese PLA General Hospital
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Changchun, China
- Jilin Province Cancer Hospital
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Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, China, 310022
- Zhejiang Cancer Hospital
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Linyi, China, 276002
- Lin Yi Tumor Hospital
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Nanjing, China, 210000
- Jiangsu Cancer Hospital
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Shanghai, China, 200030
- Shanghai Chest Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Tianjin, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Singapore, Cingapura, 169610
- National Cancer Centre
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Shatin, Hong Kong
- Prince of Wales Hospital
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Kaohsiung, Taiwan, 824
- E-Da Hospital
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Tainan, Taiwan, 704
- NCKUH
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Taoyuan County, Taiwan, 333
- Chang-Gung Memorial Hospital, Linkou
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Bangalore, Índia, 560052
- Vikram Hospital
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Bengaluru, Índia, 560027
- HCG Hospital
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Calicut, Índia, 673002
- P VS Hospital Pvt Ltd
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Chennai, Índia, 600031
- V S Hospital
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Delhi, Índia, 110092
- Max Super Speciality Hospital, Delhi
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Hyderabad, Índia, 500004
- Global Hospitals
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Hyderabad, Índia, 500034
- Basavatarakam Indo - American Cancer Hospital & Research Ins
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Jaipur, Índia, 302004
- SEAROC Cancer Centre
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Kolkata,West Bengal, Índia, 700053
- B. P. Poddar Hospital & Medial Research Ltd
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Madurai, Índia, 625 020
- Asirvatham Multispeciality Hospital
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Maharashtra, Índia, 422 004
- Curie Manavata Cancer Centre
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Maharashtra, Índia, 422005
- Shatabdi Superspeciality Hospital
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Mumbai, Índia, 400010
- Prince Aly Khan Hospital
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Pune, Índia, 411001
- Ruby Hall Clinic
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion criteria:
- locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
- presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
- male or female patients age 18 years or older (For India only, male or female patients age >=18 years and <=75 years)
adequate organ function, defined as all of the following:
- Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
- Platelet count >75,000/mm3
- Serum creatinine < 1.5 times of the upper limit of normal
- Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
- Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
Exclusion criteria:
- prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
- use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)
radiotherapy within 4 weeks prior to drug administration except as follows:
- palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
- major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
- known hypersensitivity to afatinib or any of its excipients
- history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
- Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.
childbearing potential (see Section 4.2.3) who:
- are nursing or
- are pregnant or
- are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
- history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
- previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
- known pre-existing interstitial lung disease
- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
- Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
- meningeal carcinomatosis
- symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication)
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: Afatinib
Patient will receive afatinib once daily
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Patient will receive afatinib once daily
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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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Percentage of Participants With Serious Adverse Events (SAEs)
Prazo: From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Percentage of participants with serious adverse events (SAEs).
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From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Time to Symptomatic Progression (TTSP)
Prazo: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
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Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment.
95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
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From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
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Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
Prazo: From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Percentage of participants with drug-related (afatinib-related) adverse events.
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From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Zhao J, Bai H, Wang X, Wang Y, Duan J, Chen H, Xue Z, Tian Y, Cseh A, Huang DC, Wu YL, Wang J. Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFRm+ non-small-cell lung cancer. Future Oncol. 2022 Apr;18(12):1485-1497. doi: 10.2217/fon-2021-0394. Epub 2022 Feb 4.
- Tu HY, Feng J, Shi M, Zhao J, Wang Y, Chang J, Wang J, Cheng Y, Zhu J, Tan EH, Li K, Zhang Y, Lee V, Yang CT, Su WC, Lam DC, Srinivasa BJ, Rajappa S, Ho CL, Lam KC, Hu Y, Bondarde SA, Liu X, Tian Y, Xue Z, Cseh A, Huang DC, Zhou C, Wu YL. A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naive Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China. Target Oncol. 2022 Jan;17(1):1-13. doi: 10.1007/s11523-021-00859-6. Epub 2022 Jan 12.
Links úteis
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)
30 de setembro de 2013
Conclusão Primária (Real)
6 de julho de 2018
Conclusão do estudo (Real)
6 de julho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
25 de setembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de setembro de 2013
Primeira postagem (Estimativa)
1 de outubro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de junho de 2019
Última verificação
1 de junho de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Afatinibe
Outros números de identificação do estudo
- 1200.66
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 .
Ensaios clínicos em Afatinib
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Shandong UniversityThe Affiliated Hospital of Qingdao University; Qianfoshan Hospital; The Second...Recrutamento
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Samsung Medical CenterAstraZenecaDesconhecidoCâncer de Pulmão de Células Não Pequenas Positivo com Mutação EGFRRepublica da Coréia