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

NCT00824161 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-04-23

Study results available
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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 clinical benefit, overall survival, and the safety profile of TAS-109

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

TAS-109

14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period. Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Henry Xiong, M.D., Ph.D. · The Center for Cancer and Blood Disorders

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824161 on ClinicalTrials.gov