NCT01697605已完成1 期
A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Incidence rate and category of dose limiting toxicities (DLTs)
研究概览
简要总结
This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced solid tumors with FGF-R alteration
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate organ function
排除标准
- •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.
研究组 & 干预措施
BGJ398
Experimental
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.
干预措施: BGJ398 (Drug)
结局指标
主要结局
Incidence rate and category of dose limiting toxicities (DLTs)
时间窗: First cycle of 28 days
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
次要结局
- Best overall response (BOR)(Participants will be followed for the duration of treatment, an expected average of 24 weeks.)
- Progression-free survival (PFS)(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.)
- Preliminary anti-tumor activity(Participants will be followed for the duration of treatment, an expected average of 24 weeks.)
- Overall response rate (ORR)(Participants will be followed for the duration of treatment, an expected average of 24 weeks.)
- Duration of Serious Advers Events (SAEs)(From within 21 days of first treatment to 28 days after treatment discontinuation)
- Time vs. concentration profiles(1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks)
- Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)(From within 21 days of first treatment to 28 days after treatment discontinuation)
- Changes in hematology and chemistry values(From baseline to 28 days after treatment discontinuation)
- Assessments of physical examinations, vital signs and electrocardiograms (ECGs)(Participants will be followed for the duration of treatment, an expected average of 24 weeks.)
- Duration of all Adverse Events (AEs)(From within 21 days of first treatment to 28 days after treatment discontinuation)
- Severity of all Adverse Events (AEs)(From within 21 days of first treatment to 28 days after treatment discontinuation)
- Severity of all Serious Advers Events (SAEs)(From within 21 days of first treatment to 28 days after treatment discontinuation)
研究者
研究点 (4)
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