NCT02925104已完成1 期
A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated 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
- 36
- 试验地点
- 2
- 主要终点
- Cmax for INC280
研究概览
简要总结
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
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
- •cMET dysregulated advanced solid tumor
- •At least one measurable lesion as defined by RECIST 1.1
- •Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1
- •Adequate organ function
- •ECOG performance status (PS) ≤ 1
排除标准
- •Prior treatment with crizotinib or any other cMET or HGF inhibitor
- •Known hypersensitivity to any of the excipients of INC280
- •Symptomatic central nervous system (CNS) metastases who are neurologically unstable
- •Presence or history of a malignant disease other than the study related cancer
- •Clinically significant, uncontrolled heart diseases
- •Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities
- •Major surgery within 4 weeks prior to starting INC280
- •Impairment of GI function
- •Patients receiving unstable or increasing doses of corticosteroids
- •Patients receiving treatment with any enzyme-inducing anticonvulsant
- •Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply
研究组 & 干预措施
INC280
Experimental
干预措施: INC280 (Drug)
结局指标
主要结局
Cmax for INC280
时间窗: C1D1, C1D7, C1D15, C2D1, C3D1
Category of DLTs
时间窗: During the first 28 days on INC280 treatment
Frequency of DLTs
时间窗: During the first 28 days on INC280 treatment
Incidence of Dose limiting toxiticites (DLTs)
时间窗: During the first 28 days on INC280 treatment; cycle = 21 days
AUClast for INC280
时间窗: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
AUCtau for INC280
时间窗: C1D1, C1D7, C1D15, C2D1, C3D1
Tmax
时间窗: C1D1, C1D7, C1D15, C2D1, C3D1
次要结局
- Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).(Screening, until 30 days post-treatment)
研究者
研究点 (2)
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