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

Stopped early · Phase 2

Conditions studied: Advanced Colorectal Cancer

In brief

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

Key facts

Study ID

NCT00824161

Run by

Taiho Pharmaceutical Co., Ltd.

People needed

28

Starts

2009-01-01

Expected to finish

2010-12-01

Last updated by the study team

2012-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Cancer Institute — East 34th Street, New York, New York, United States
• The University of Texas M.D. Anderson Cancer Center — Holcombe Boulevard, Houston, Texas, United States
• The Center for Cancer and Blood Disorders — West Magnolia Avenue, Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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