Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

This is an open-label study to provide expanded access to TAS-102 prior to its commercial
availability for patients with metastatic colorectal cancer who have been previously treated
with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based
chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an
anti-epidermal growth factor receptor (EGFR) therapy.

Serious adverse event information (whether or not related to TAS-102) as well as reports of
pregnancy, overdose, or medication error will reported. In addition, all grades of adverse
drug reactions (ADRs, adverse events related to study medication) and any adverse event that
results in treatment discontinuation will be recorded as study data on CRFs.

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