Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD
as a TAS-102 component compared with FTD alone in patients with advanced solid tumors
(excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or
FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the
extension phase.

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)