Gastric Cancer
Conditions
Keywords
Advanced/recurrent gastric cancer
Brief summary
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.
Interventions
DRUGARQ 197
Orally twice daily administration of ARQ 197
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor effect | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. | Disease control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor effect | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. | Tumor response |
| Progression-free survival | Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey. | — |
| Overall survival | Survival was confirmed by biweekly inquiry during the study, and by follow up survey. | — |
| Pharmacokinetic profile | Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29. | Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197 |
| Adverse events | Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study. | — |
Countries
Japan, South Korea
Outcome results
None listed