Phase III Clinical Study of ABI-007
Phase 3
- Conditions
- unresectable/recurrent gastric cancer patients refractory to prior chemotherapy containing fluoropyrimidine
- Registration Number
- JPRN-jRCT2080222013
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 730
Inclusion Criteria
Signed, written informed consent.
- Histologically or cytologically confirmed gastric adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Exclusion Criteria
- Past history of severe drug hypersensitivity
- Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE).
- Principal Investigators'(sub investigators') judgment on ineligibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival:OS<br>Continuous survival confirmation
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events and adverse drug reactions<br> Anti-tumor efficacy and progression-free survival (PFS)<br><br>RECIST (ver.1.1)