Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC
Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study was a multicenter, open, single-arm, Ib-stage expanded clinical study.
Part I：On the basis of Ia-stage dose escalation study, a safe and effective dose of -300 mg, 450 mg, 600 mg and 800 mg was selected to enlarge the enrollment study in patients with c-Met-dysregulated advanced NSCLC, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.
Part II：On the basis of the completed research results of Ia stage and part I, a safe and effective dose of 400 mg twice a day (bid) was selected to conduct an expanded enrollment study in NSCLC patients with MET exon 14 skipping alterations, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Yuankai Shi, MD
- E-mail: syuankai@yahoo.cn
Locais de estudo
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Anhui
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Hefei, Anhui, China, 230601
- Recrutamento
- The Second Affiliated Hospital of Anhui Medical University
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Contato:
- Hui Zhao, MD
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Beijing
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Beijing, Beijing, China, 100032
- Recrutamento
- Peking Union Medical College Hospital
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Contato:
- Mengzhao Wang, MD
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Beijing, Beijing, China, 100142
- Recrutamento
- Beijing Cancer Hospital
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Contato:
- Ziping Wang, MD
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Beijing, Beijing, China, 100021
- Recrutamento
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
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Contato:
- Yuankai Shi, MD
- E-mail: syuankaipumc@126.com
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Hebei
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Shijiazhuang, Hebei, China, 050011
- Ainda não está recrutando
- Fourth Hospital of Hebei Medical University
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Investigador principal:
- Mingxia Wang
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Investigador principal:
- Da Jiang, MD
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Ainda não está recrutando
- Affiliated Cancer Hospital of Harbin Medical University
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Contato:
- Yan Yu, MD
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Liaoning
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Shenyang, Liaoning, China, 110001
- Recrutamento
- The First Hospital of China Medical University
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Contato:
- Yunpeng Liu, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
- Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy ≥12 weeks
- Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations；Must haved evidence of MET exon 14 skipping alterations in blood and/or tissue samples.
- Adequate bone marrow, hepatic, and renal function
- Patients of child bearing potential must agree to take contraception during the study and for 3 months after the last day of treatment
- Signed Informed Consent Form
Exclusion Criteria:
- Prior or current treatment with the type II of c-MET inhibitor or HGF/c-Met antibody therapy
- Confirmed ALK or ROS1 rearrangement
- Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs,the tpye I of MET TKIs, etc.) within 14 days or 5 half-life
- Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks
- Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
- Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
- Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- History of organ transplant; had surgery or severe injury within 4 weeks
- Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）
- Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.
- Pregnant (positive pregnancy test) or lactating women
Plano de estudo
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 |
|---|---|
|
Experimental: BPI-9016M
Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day. |
Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Participants with Adverse Events
Prazo: 18 months
|
18 months
|
|
Objective Response Rate
Prazo: 16 weeks
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16 weeks
|
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Disease Control Rate
Prazo: 16 weeks
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16 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Sobrevivência geral
Prazo: 24 meses
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24 meses
|
|
Sobrevivência livre de progressão
Prazo: 18 meses
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18 meses
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AUCss
Prazo: 4 weeks
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4 weeks
|
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Css-min
Prazo: 18 months
|
18 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- BD-CM-I02
Plano para dados de participantes individuais (IPD)
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