A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
研究概览
简要总结
This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
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
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
- •Voluntary written informed consent for study participation must be obtained
- •A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
- •History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
- •ECOG PS of 0 or 1
- •Life expectancy of ≥3 months
- •Poor metabolizers as defined by CYP2C19 genotype
排除标准
- •Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
- •Surgery for cancer within 28 days prior to ARQ 197 dose
- •Active double cancer
- •Known symptomatic brain metastases
- •An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
- •Pregnant or lactating
- •Subjects who wish to have a child and who would not agree to use contraceptive measures
研究组 & 干预措施
ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
干预措施: ARQ 197 and Erlotinib (Drug)
结局指标
主要结局
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
时间窗: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
次要结局
- Antitumor activity(Baseline, and then every 6 week of imaging until discontinuation criteria met)
- Pharmacokinetic profile of Erlotinib(At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment)
- Pharmacokinetic profile of ARQ 197(Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment)