Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

Inclusion Criteria

• Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
• Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
• Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Is able to take medications orally (ie, no feeding tube).
• Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
• Has adequate organ function as defined by protocol defined labs.
• Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria

• Has certain serious illnesses or medical conditions
• Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration.
• Has previously received TAS-102.
• Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
• Is a pregnant or lactating female.