Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

This is a Phase 1, open-label study evaluating the mass balance of FTD and TPI after a
single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI. The study will be
conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the
mass balance part, patients will receive continued treatment with TAS-102 during the study
extension part.

Inclusion Criteria:

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

2. ECOG performance status of 0 or 1

3. Is able to take medications orally

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

5. 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 a medical condition that jeopardizes or impairs ability to collect representative
excreta

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

6. Known sensitivity to TAS-102 or its components

7. Is a pregnant or lactating female

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

9. Is an occupationally exposed worker as defined by relevant ionizing radiation
regulations

10. Has been exposed to 14C in the last 12 months