Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Key facts

Study ID

NCT01607957

Run by

Taiho Oncology, Inc.

People needed

800

Starts

2012-06-17

Expected to finish

2016-05-23

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has provided written informed consent
• Has adenocarcinoma of the colon or rectum
• Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
• ECOG performance status of 0 or 1
• Is able to take medications orally
• Has adequate organ function (bone marrow, kidney and liver)
• Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

You may not qualify if…

• Certain serious illnesses or medical condition(s)
• Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
• Has received TAS-102
• Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
• Is a pregnant or lactating female

Where it is running

• California Cancer Associates for Research and Excellence — Fresno, California, United States
• Ronald H. Yanagihara, MD — Gilroy, California, United States
• LAC and USC Medical Center — Los Angeles, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• San Jose Medical Group — San Jose, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• MD Anderson Cancer Center Orlando — Orlando, Florida, United States
• Illinois Cancer Care, P.C. — Peoria, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
• Ochsner Clinic Fndtn — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Jefferson City Medical Group — Jefferson City, Missouri, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Hickman Cancer Center at Flower Hospital — Sylvania, Ohio, United States
• Hematology/Oncology Associates of Fredericksburg — Fredericksburg, Virginia, United States
• Royal North Shore Hospital — Sydney, New South Wales, Australia
• The Queen Elisabeth Hospital — Woodville South, South Australia, Australia
• Arizona Center for Cancer Care — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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