Advanced/recurrent gastric cancer
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =< months
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor effect (disease control) | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor effect (tumor response) Progression-free survival Overall survival Pharmacokinetics Safety | — |
Outcome results
None listed