Study of ARQ 197 Monotherapy (ARQ 197-004)

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: ARQ 197

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152645

ARQ 197-004

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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