Spots Global Cancer Trial Database for Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
Official Title: An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy
Study ID: NCT02286492
Conditions
Interventions
Study Description
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.
Detailed Description: This is an open-label study to provide expanded access to TAS-102 prior to its commercial availability for patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Contact Details
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