Study of ARQ 197 Monotherapy

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

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 ≥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