Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

• Status: Completed
• Trial end date: 2016-05-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

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

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Trifluridine

Criteria

Inclusion Criteria:

1. Has provided written informed consent

2. Has adenocarcinoma of the colon or rectum

3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer

4. ECOG performance status of 0 or 1

5. Is able to take medications orally

6. Has adequate organ function (bone marrow, kidney and liver)

7. 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.

Exclusion Criteria:

1. Certain serious illnesses or medical condition(s)

2. 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

3. Has received TAS-102

4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies

5. Is a pregnant or lactating female