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

• ClinicalTrials.gov Identifier: NCT00824161
• Recruitment Status: Terminated
• First Posted: January 16, 2009
• Results First Posted: August 17, 2011
• Last Update Posted: April 23, 2012
• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Taiho Pharmaceutical Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Advanced Colorectal Cancer	Drug: TAS-109	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
• Study Start Date: January 2009
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; TAS-109	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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Progression Free Survival [ Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. ]
   The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.

Secondary Outcome Measures :

1. Antitumor Activity [ Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. ]
   Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.
2. Overall Survival [ Time Frame: From the initial treatment until 12 months after enrollment of the last patient. ]
   Overall survival is defined as the period from the date of first dose of TAS-109 to death date.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

NYU Cancer Institute

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

United States, Texas

The University of Texas M.D. Anderson Cancer Center

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

The Center for Cancer and Blood Disorders

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

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Henry Xiong, M.D., Ph.D.; The Center for Cancer and Blood Disorders

More Information

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00824161
• Other Study ID Numbers: TAS109-0403
• First Posted: January 16, 2009
• Results First Posted: August 17, 2011
• Last Update Posted: April 23, 2012
• Last Verified: April 2012

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases