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

NCT ID: NCT00824161

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

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

Conditions

Advanced Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

TAS-109

Group Type: EXPERIMENTAL

TAS-109

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Xiong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Center for Cancer and Blood Disorders

Locations

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

Countries

United States

Other Identifiers

TAS109-0403

Identifier Type: -

Identifier Source: org_study_id