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

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Trifluridine

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.