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

Taiho Pharma

Status and phase

Completed

Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: TAS-102

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01955837

10040090

Details and patient eligibility

About

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

Full description

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).

Enrollment

406 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.