跳至主要内容
临床试验/jRCT2031260096
jRCT2031260096招募中不适用

A Phase 1, Open-Label Study to Evaluate the Effect of Food on the Pharmacokinetics of Zipalertinib (TAS6417 FE study)

未提供0 个研究点目标入组 16 人开始时间: 待定
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
16

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Provided written informed consent.
  • Is >= 18 years of age at the time of informed consent.
  • Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC, characterized at or after the time of locally advanced or metastatic disease diagnosis by EGFR mutation.
  • Refractory to prior therapies, unable to receive generally accepted standard therapies, or unwilling to receive such therapies.

排除标准

  • Documented EGFR C797S mutation-positive status Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC
  • Have any unresolved toxicity of Grade >= 2 from previous anticancer treatment except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor.
  • Have allergy to any components of the high-fat test meal.
  • Use tobacco products.

研究者

发起方
未提供

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