A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors

Inclusion Criteria

• •1. Provided written consent
• •2. Is 18 years of age or older
• •3. Has histologically or cytologically confirmed advanced, measurable or non-measurable metastatic solid tumors for which the patients have no available therapy to convey clinical benefit Expansion Phase only: The target population should include at least
• •1. 12 patients with breast cancer for whom 5 FU chemotherapy is the standard treatment
• •2. 28 patients with refractory colorectal cancer.
• •4. May have received prior therapies for advanced or metastatic disease
• •5. Expansion Phase only: Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009), ie, has at least one measurable lesion
• •6. Has ECOG performance status 0 or 1 on Cycle 1, Day 1
• •7. Is able to take medications orally
• •8. Has adequate organ function as defined by protocol
• •9. Women of childl-bearing potential must have a negative pregnancy test within 7 days prior to starting the study drug. Beth males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose
• •10. Is willing to and able to comply with scheduled visits and study procedures.