Advanced/recurrent non-small-cell lung cancer
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile Antitumor activity | — |
Outcome results
None listed