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

NCT01955837 ↗

Phase 3 Completed 406 enrolled Taiho Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2013-09
Primary completion: 2016-02-16
Completion: 2016-06-30

Outcome

Met primary endpoint

registry analysis (superiority test); TAS-102（Trifluridine/Tipiracil） vs Placebo; p = 0.035; Hazard Ratio (HR) 0.79 (95% CI 0.62 to 0.99); Log Rank NCT01955837 ↗

paper Risk of death was significantly lower in the trifluridine/tipiracil arm than in the placebo arm PMID 29215955 ↗

Publications

Xu J, Kim TW, Shen L, Sriuranpong V, Pan H, Xu R, Guo W, Han SW, Liu T, Park YS, Shi C, Bai Y, Bi F, Ahn JB, Qin S, Li Q, Wu C, Ma D, Lin D, Li J. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study. J Clin Oncol. 2018 Feb 1;36(4):350-358. doi: 10.1200/JCO.2017.74.3245. Epub 2017 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TAS-102	Small molecule	35 mg/m2	Oral