Phase II study of ABI-007 in combination with Ramucirumab
Phase 2
- Conditions
- nresectable/recurrent gastric cancer patients refractory to prior chemotherapy containing fluoropyrimidine
- Registration Number
- JPRN-jRCT2080223034
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Signed, written informed consent.
-Histologically or cytologically confirmed gastric adenocarcinoma.
-Eastern Cooperative Oncology Group performance status of 0-1
Exclusion Criteria
-Past history of severe drug hypersensitivity
-Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE).
-Principal Investigator's (sub investigator's) judgment on ineligibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate<br>RECIST ver.1.1
- Secondary Outcome Measures
Name Time Method Progression free survival, overall survival, incidence and severity of adverse events and treatment related adverse events<br>RECIST ver.1.1<br>CTCAE v4.0