Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy
1 other identifier
expanded_access
N/A
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedSeptember 5, 2024
August 1, 2024
November 5, 2014
August 30, 2024
Conditions
Interventions
At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Alabama Oncology
Birmingham, Alabama, 35211, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
California Cancer Associates for Research and Excellence
Fresno, California, 93720, United States
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, 95020, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, 94115, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
University of Florida Health Davis Cancer Center
Gainesville, Florida, 32610, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615-7828, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
University of Rochester
Rochester, New York, 14642, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, 18512, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Fox Valley Hematology & Oncology
Appleton, Wisconsin, 54915, United States
Related Publications (1)
Mayer RJ, Hochster HS, Cohen SJ, Winkler R, Makris L, Grothey A. Safety of trifluridine/tipiracil in an open-label expanded-access program in elderly and younger patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2018 Dec;82(6):961-969. doi: 10.1007/s00280-018-3686-5. Epub 2018 Oct 22.
PMID: 30350179DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 7, 2014
Last Updated
September 5, 2024
Record last verified: 2024-08