Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia

Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies

To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.

This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Inclusion Criteria:

• Has provided written informed consent
• Has adenocarcinoma of the colon or rectum
• Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Is able to take medication orally
• Has adequate organ function (bone marrow, kidney and liver)
• 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.