Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

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Conditions studied: Colorectal Cancer Metastatic

In brief

The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

Key facts

Study ID

NCT02286492

Run by

Taiho Oncology, Inc.

Last updated by the study team

2024-09-05

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

• Alabama Oncology — Birmingham, Alabama, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• California Cancer Associates for Research and Excellence — Fresno, California, United States
• Global Cancer Research Institute (GCRI), Inc. — Gilroy, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Pacific Hematology Oncology Associates (PHOA) — San Francisco, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• University of Florida Health Davis Cancer Center — Gainesville, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Illinois CancerCare, P.C. — Peoria, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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