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
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Yuankai Shi, MD
- 邮箱:syuankai@yahoo.cn
学习地点
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Anhui
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Hefei、Anhui、中国、230601
- 招聘中
- The Second Affiliated Hospital of Anhui Medical University
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接触:
- hui zhao, MD
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Beijing
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Beijing、Beijing、中国、100032
- 招聘中
- Peking Union Medical College Hospital
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接触:
- Mengzhao Wang, MD
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Beijing、Beijing、中国、100142
- 招聘中
- Beijing Cancer Hospital
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接触:
- Ziping Wang, MD
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Beijing、Beijing、中国、100021
- 招聘中
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
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接触:
- Yuankai Shi, MD
- 邮箱:syuankaipumc@126.com
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Hebei
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Shijiazhuang、Hebei、中国、050011
- 尚未招聘
- Fourth Hospital of Hebei Medical University
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首席研究员:
- Mingxia Wang
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首席研究员:
- Da Jiang, MD
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Heilongjiang
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Harbin、Heilongjiang、中国、150081
- 尚未招聘
- Affiliated Cancer Hospital of Harbin Medical University
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接触:
- Yan Yu, MD
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Liaoning
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Shenyang、Liaoning、中国、110001
- 招聘中
- The First Hospital of China Medical University
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接触:
- Yunpeng Liu, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Participants with Adverse Events
大体时间:18 months
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18 months
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Objective Response Rate
大体时间:16 weeks
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16 weeks
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Disease Control Rate
大体时间:16 weeks
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16 weeks
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次要结果测量
结果测量 |
大体时间 |
---|---|
总生存期
大体时间:24个月
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24个月
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无进展生存期
大体时间:18个月
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18个月
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AUCss
大体时间:4 weeks
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4 weeks
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Css-min
大体时间:18 months
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18 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
BPI-9016M的临床试验
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Betta Pharmaceuticals Co., Ltd.尚未招聘