A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
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:
- 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