Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
- 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.
- 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.
This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study
evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in
participants with metastatic gastric cancer who have previously received at least 2 prior
regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to
TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).
Trial Phase Phase III
Trial Type Treatment
Taiho Pharmaceutical Company Limited
- Primary ID TO-TAS-102-302
- Secondary IDs NCI-2016-00338, 2015-002683-16, s15-01245
- Clinicaltrials.gov ID NCT02500043