Status:
COMPLETED
Study of ARQ 197 Monotherapy
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
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 contr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01152645
Start Date
June 1 2010
End Date
August 1 2011
Last Update
March 15 2017
Active Locations (2)
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1
Nagoya, Japan
2
Seoul, South Korea