NCT01546428已完成1 期
A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
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
- 44
- 试验地点
- 1
- 主要终点
- Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
研究概览
简要总结
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Good organ (hepatic, kidney, BM) function at screening/baseline visit.
- •Exclusion criteria:
- •Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC
- •Undergone a bone marrow or solid organ transplant.
- •Women who are pregnant or breast feeding.
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
INC280
Experimental
干预措施: INC280 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
时间窗: 4 weeks
Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
次要结局
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values(4 months)
- Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2(1 month)
- Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM(4 months)
研究者
研究点 (1)
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