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临床试验/JPRN-jRCT2080221009
JPRN-jRCT2080221009未知1 期

A Phase I Study of ARQ 197 in Combination with Erlotinib in Patients with Advanced/Recurrent Non-Small-Cell Lung Cancer

Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2010年2月17日最近更新:
适应症

试验速览

阶段
1 期
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

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

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
  • - Positive for HBs antigen, HCV antibody or HIV antibody
  • - 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

研究者

发起方
Kyowa Hakko Kirin Co., Ltd.

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