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

Phase 2

Terminated

• Conditions: Advanced Colorectal Cancer
• Interventions: Drug: TAS-109

• Registration Number: NCT00824161
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-16
• Primary Completion: 2009-11
• Study Completion: 2010-12
• Results First Submitted: 2011-06-21
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-17
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TAS-109	TAS-109

Primary Outcome Measures

Name	Time	Method
Percentage of Progression Free Survival	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

Name	Time	Method
Antitumor Activity	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.
Overall Survival	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.

Trial Locations

Locations (3)

NYU Cancer Institute; 🇺🇸 East 34th Street, New York, New York, United States

The Center for Cancer and Blood Disorders; 🇺🇸 West Magnolia Avenue, Fort Worth, Texas, United States

The University of Texas M.D. Anderson Cancer Center; 🇺🇸 Holcombe Boulevard, Houston, Texas, United States