Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy - TAS-102 Phase II GC

ational Cancer Center Hospital East0 sites28 target enrollmentMarch 2, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 2, 2012

End Date

March 1, 2014

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ational Cancer Center Hospital East

•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.