Status:

TERMINATED

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

Lead Sponsor:

Taiho Pharmaceutical Co., Ltd.

Conditions:

Advanced Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 clin...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT00824161

Start Date

January 1 2009

End Date

December 1 2010

Last Update

April 23 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

NYU Cancer Institute

East 34th Street, New York, New York, United States, NY 10016

2

The University of Texas M.D. Anderson Cancer Center

Holcombe Boulevard, Houston, Texas, United States, TX 77030

3

The Center for Cancer and Blood Disorders

West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104