NCT00742105终止1 期
A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicity (DLT) at each dose level
研究概览
简要总结
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •World Health Organization (WHO) Performance Status of ≤ 2
- •Histologically-confirmed, advanced solid tumors
- •Progressive, recurrent unresectable disease
排除标准
- •Hematopoietic:
- •No diabetes mellitus or history of gestational diabetes mellitus
- •No acute or chronic renal disease
- •No acute or chronic liver disease
- •No acute or chronic pancreatitis
- •No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
- •No acute myocardial infarction or unstable angina pectoris within the past 3 months
- •Not pregnant or nursing and fertile patients must use barrier contraceptives
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BGT226
Experimental
干预措施: BGT226 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicity (DLT) at each dose level
时间窗: 22-28 days
次要结局
- Safety measured by type, frequency and severity of adverse drug reactions(Every 4 weeks)
- Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling(Baseline, every 3 weeks)
- Preliminary Efficacy od BGT226(Every 8 weeks)
- Biomarkers: Percentage of change, pre- versus post-treatment(Every month)
研究者
研究点 (1)
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