Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer

The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109

Inclusion Criteria:

• Histologically confirmed colorectal adenocarcinoma
• Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
• Have at least one measurable tumor, as defined by RECIST
• Must be capable of maintaining a central venous line access

Exclusion Criteria:

• Had previous anti-tumor therapy in the 3 weeks prior to study entry
• Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
• Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix