Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy
- Conditions
- advanced gastric cancer
- Registration Number
- JPRN-UMIN000007421
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Not provided
1) Administration of chemotherapy within 2 weeks prior to enrollment. 2) Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks. 3) Investigational drugs were administrated within 4 weeks prior to enrollment. 4) Prior chemotherapy with TAS-102. 5) Known hypersensitivity to TAS-102 or excipients. 6) Patients with CNS metastases. 7) Malignant pleural effusion, ascites or cardiac effusion requiring invasive treatment. (such as ascites drainage) 8) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 9) Any severe and/or uncontrolled medical conditions. 10) Positive HBs antigen or HCV antibody. Known positive serology for HIV. 11) Chronic treatment with steroids or another immunosuppressive agent. 12) Not use adequate methods of contraception. (duplex barrier method or intrauterine device) 13) Patient is unwilling or unable to comply with the protocol. 14) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate (DCR)
- Secondary Outcome Measures
Name Time Method Response rate (RR) Progression free survival (PFS) Overall survival (OS) Adverse events PK parameter