A Phase I Study of ARQ 197 in Combination with Erlotinib
- Conditions
- Advanced/recurrent non-small-cell lung cancer
- Registration Number
- JPRN-jRCT2080221318
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method