Phase II study of ARQ 197 monotherapy
- Conditions
- Advanced/recurrent gastric cancer
- Registration Number
- JPRN-jRCT2080221133
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antitumor effect (disease control)
- Secondary Outcome Measures
Name Time Method Antitumor effect (tumor response)<br>Progression-free survival<br>Overall survival<br>Pharmacokinetics <br>Safety