NCT01772797已完成1 期
A Phase Ib, Open-label, Dose Escalation Study of LDK378 and AUY922 in Patients With ALK-rearranged Non-small Cell Lung Cancer
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
- 22
- 试验地点
- 5
- 主要终点
- Incidence rate of Dose Limiting Toxicities (DLT)
研究概览
简要总结
The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.
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
- •locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor
- •tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
- •disease that can be evaluated by RECIST v1.1 and measurable disease
排除标准
- •central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease
- •history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
- •clinically significant cardiac dysfunction
- •inadequate end organ function as defined by specified laboratory values
- •use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
- •use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment
- •clinically significant, uncontrolled impaired gastrointestinal function or GI disease
- •prior treatment with a HSP90 inhibitor
- •radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
- •pregnant or nursing women
- •history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
研究组 & 干预措施
LDK378 and AUY922
Experimental
干预措施: LDK378 (Drug)
LDK378 and AUY922
Experimental
干预措施: AUY922 (Drug)
结局指标
主要结局
Incidence rate of Dose Limiting Toxicities (DLT)
时间窗: up to day 28 after the patient's first dose
cycle = within the first 28 days of patient's first dose
次要结局
- Overall response rate (ORR)(30 months)
- Plasma PK parameter of LDK378 and AUY922: Cmax(30 months)
- Plasma PK parameter of LDK378 and AUY922: AUCtau(30 months)
- Number of patients with adverse events(30 months)
- Assessments of dose interruptions, reductions, and dose intensity(30 months)
- Duration of Response (DoR)(30 months)
- Plasma PK parameter of LDK378 and AUY922: AUClast(30 months)
- Plasma PK parameter of LDK378 and AUY922: Racc(30 months)
- Changes in laboratory values(30 months)
- Assessments of electrocardiograms(30 months)
- Time to Response (TTR)(30 months)
- Plasma PK parameter of LDK378 and AUY922: Tmax(30 months)
- Progression free survival (PFS)(30 months)
- Number of patients with serious adverse events(30 months)
- Plasma PK parameter of LDK378 and AUY922: Cmin(30 months)
研究者
研究点 (5)
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