Study of ARQ 197 Monotherapy

Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer

A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.

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