NCT01580735已完成2 期
A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Objective Response Rate
研究概览
简要总结
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
- •Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function
排除标准
- •Prior therapy with a c-Met inhibitor.
- •Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
- •Major surgical procedure within 4 weeks prior to randomization
- •Known symptomatic brain metastases.
研究组 & 干预措施
ARQ 197
Experimental
干预措施: ARQ 197 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 6 months
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
次要结局
- To examine the overall survival(30 months)
- To estimate the safety profile(30 months)
- To examine the disease control rate(30 months)
- To examine the progression free survival(30 months)
研究者
相似试验
终止
3 期
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A Study of ARQ 197 in Combination With ErlotinibNon-small-cell Lung CancerNCT01069757Kyowa Kirin Co., Ltd.16
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A Study of ARQ 197 in Combination With ErlotinibAdvanced/Recurrent Non-small-cell Lung CancerNCT01251796Kyowa Kirin Co., Ltd.9
进行中（未招募）
不适用
A Randomized Phase 2 Study of Erlotinib plus ARQ 197 versus Erlotinib plus Placebo in Previously Treated Patients with Locally Advanced or Metastatic Non-Small Cell Lung CancerEUCTR2007-004634-17-LVArQule Inc.154
进行中（未招募）
不适用
A Randomized Phase 2 Study of Erlotinib plus ARQ 197 versus Erlotinib plus Placebo in Previously Treated Patients with Locally Advanced or Metastatic Non-Small Cell Lung Canceron-Small Cell Lung Cancer (phase 3b/4)MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVEUCTR2007-004634-17-DEArQule Inc.193