NCT02145637已完成1 期
Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)
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
- 30
- 主要终点
- To set a recommended phase II dose (RP2D)
研究概览
简要总结
This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.
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
- •Stage 4 NSCLC patients
- •disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
- •Men and women aged 20 years or older
- •Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
- •ECOG 0 or 1
- •able to orally take and retain drug
- •have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
- •have proper hematological, renal, and hepatic functions
- •intention to use an acceptable contraception
- •able to read and understand the informed consent form
排除标准
- •previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
- •Clinically significant gastrointestinal disorder or malabsorption syndrome
- •Acute digestive disorder
- •major organ failure
- •Significant cardiac disorders
- •major operation of a main organ in 4 weeks
- •Untreated symptomatic brain metastasis
- •pregnant or nursing
- •previously diagnosed Interstitial lung disease(ILD)
- •previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib
- •previously experienced hypersensitivity to an ingredient of the study drug
- •must receive CYP3A4 inducer or inhibitor persistently during the study period.
- •HIV positive or active hepatitis
- •threatening patient's safety is predicted
研究组 & 干预措施
Afatinib plus Ruxolitinib combination (single arm)
Experimental
干预措施: Afatinib plus Ruxolitinib combination therapy (Drug)
结局指标
主要结局
To set a recommended phase II dose (RP2D)
时间窗: 36 days
We will set a recommended phase II dose (RP2D) using conventional 3+3 deisgn.
次要结局
- Overall survival (OS)(1year)
- Safety and tolerability (dose relating toxicity; DLT)(1year)
- Progression free survival (PFS)(1year)
- Overall response rate (ORR)(1year)
- Pharmacodynamic biomarker(1year)
研究者
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