Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
NCT ID: NCT02286492
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
NCT01607957
A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC
NCT02860546
Phase 2 Study of CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Relapsed and/or Refractory Metastatic Colorectal Cancer
NCT06039202
Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
NCT06856187
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
NCT00824161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAS-102
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has adenocarcinoma of the colon or rectum
3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Has adequate organ function (bone marrow, kidney and liver)
7. 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.
Exclusion Criteria
2. 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
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taiho Oncology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
The Mark H. Zangmeister Center
Columbus, Ohio, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Fox Valley Hematology & Oncology
Appleton, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TO-TAS-102-401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.