Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
Inclusion Criteria:
- Japanese or Korean with voluntary written informed consent for study participation
- A histologically or cytologically confirmed advanced/recurrent gastric cancer
- One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
- At least one measurable lesion
- ECOG performance status of 0 or 1
- Life expectancy ≥3 months
Exclusion Criteria:
- Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
- Confirmed other tumors than gastric cancer within 5 years prior to the first dose of
ARQ 197
- Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2
weeks prior to the first dose of ARQ 197
- Positive for HIV antibody
- Known symptomatic brain metastasis
- Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or
operation history for gastrointestinal disorders
- Uncontrolled concomitant disease
- Patients who wish to have a child and who would not agree to use contraceptive
measures
- Pregnant or lactating