Overview

Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Taiho Oncology, Inc.
Treatments:
Pharmaceutical Solutions
Trifluridine
Criteria
Inclusion Criteria:

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy
exists

3. ECOG performance status of 0 or 1

4. Is able to take medications orally

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

6. 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. Has had certain other recent treatment e.g. anticancer therapy, received
investigational agent, within the specified time frames prior to study drug
administration

2. Certain serious illnesses or medical condition(s)

3. Has had either partial or total gastrectomy

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

5. Known sensitivity to TAS-102 or its components

6. Is a pregnant or lactating female

7. Refuses to use an adequate means of contraception (including male patients)