A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer)

3. Has normal hepatic function, mild, moderate, or severe hepatic impairment

4. ECOG performance status of ≤2

5. Is able to take medications orally

6. Has adequate organ function

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

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, shunt in the liver 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