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

Study Overview
=================
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

Official Title
-----------------
A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer

Conditions
-----------------
Advanced Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: TAS-109


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TAS-109 | Drug: TAS-109<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Progression Free Survival | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor Activity | 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. | From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. | 
| Overall Survival | Overall survival is defined as the period from the date of first dose of TAS-109 to death date. | From the initial treatment until 12 months after enrollment of the last patient. |