A Phase I Study of Oral BGJ398 in Asian Patients
2020年12月6日 更新者：Novartis Pharmaceuticals
A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
研究概览
详细说明
This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.
研究类型
介入性
注册 (实际的)
9
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangzhou、中国、510060
- Novartis Investigative Site
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Guangdong
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Guangzhou、Guangdong、中国、51000
- Novartis Investigative Site
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Sichuan
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Chengdu、Sichuan、中国、610041
- Novartis Investigative Site
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Aichi
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Nagoya-city、Aichi、日本、466-8560
- Nagoya University Hospital
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Chiba
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Kashiwa、Chiba、日本、277-8577
- National Cancer Center Hospital East (NCEE)
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Hyogo
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Kobe-shi、Hyogo、日本、650-0017
- Novartis Investigative Site
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Osaka
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Sayama、Osaka、日本、589 8511
- Novartis Investigative Site
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Shizuoka
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Sunto-gun、Shizuoka、日本、411-8777
- Shizuoka Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with advanced solid tumors with FGF-R alteration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ function
Exclusion Criteria:
- Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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：BGJ398
Eligible participants received oral BGJ398 once daily or twice daily.
Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence rate and category of dose limiting toxicities (DLTs)
大体时间：First cycle of 28 days
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Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
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First cycle of 28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
大体时间：From within 21 days of first treatment to 28 days after treatment discontinuation
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To characterize the safety and tolerability of oral BGJ398
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From within 21 days of first treatment to 28 days after treatment discontinuation
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Changes in hematology and chemistry values
大体时间：From baseline to 28 days after treatment discontinuation
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hematology and chemistry values
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From baseline to 28 days after treatment discontinuation
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Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
大体时间：Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Time vs. concentration profiles
大体时间：1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
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To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites
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1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
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Preliminary anti-tumor activity
大体时间：Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Assessed based on RECIST version 1.1
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Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Best overall response (BOR)
大体时间：Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Assessed by investigator per RECIST version 1.1.
BOR is the best response recorded until disease progression.
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Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Overall response rate (ORR)
大体时间：Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Assessed by investigator per RECIST version 1.1.
ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
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Participants will be followed for the duration of treatment, an expected average of 24 weeks.
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Progression-free survival (PFS)
大体时间：From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
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PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.
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From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
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Duration of all Adverse Events (AEs)
大体时间：From within 21 days of first treatment to 28 days after treatment discontinuation
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To characterize the safety and tolerability of oral BGJ398
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From within 21 days of first treatment to 28 days after treatment discontinuation
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Duration of Serious Advers Events (SAEs)
大体时间：From within 21 days of first treatment to 28 days after treatment discontinuation
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To characterize the safety and tolerability of oral BGJ398
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From within 21 days of first treatment to 28 days after treatment discontinuation
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Severity of all Adverse Events (AEs)
大体时间：From within 21 days of first treatment to 28 days after treatment discontinuation
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To characterize the safety and tolerability of oral BGJ398
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From within 21 days of first treatment to 28 days after treatment discontinuation
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Severity of all Serious Advers Events (SAEs)
大体时间：From within 21 days of first treatment to 28 days after treatment discontinuation
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To characterize the safety and tolerability of oral BGJ398
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From within 21 days of first treatment to 28 days after treatment discontinuation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年10月19日
初级完成 (实际的)
2019年2月7日
研究完成 (实际的)
2019年2月7日
研究注册日期
首次提交
2012年9月19日
首先提交符合 QC 标准的
2012年9月28日
首次发布 (估计)
2012年10月2日
研究记录更新
最后更新发布 (实际的)
2020年12月8日
上次提交的符合 QC 标准的更新
2020年12月6日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他研究编号
- CBGJ398X1101
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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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.
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