Suspended
A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
What is being tested
TAS-109
Drug
Who is being recruted
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: January 2009
Summary
Principal SponsorTaiho Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2009
Actual date on which the first participant was enrolled.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 TitleA Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
Principal SponsorTaiho Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
4 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTAS-109
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Suspended
NYU Cancer Institute
East 34th Street, New York, United StatesOpen NYU Cancer Institute in Google MapsSuspended
The University of Texas M.D. Anderson Cancer Center
Holcombe Boulevard, Houston, United StatesSuspended
The Center for Cancer and Blood Disorders
West Magnolia Avenue, Fort Worth, United StatesSuspended3 Study Centers