Official Title
An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy
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.

Approved for marketing
Colorectal Cancer Metastatic

Drug: 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

Inclusion Criteria:

1. Has provided written informed consent

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:

1. Certain serious illnesses or medical condition(s)

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years
United States

Alabama Oncology
Birmingham, Alabama, 35211

Mayo Clinic
Scottsdale, Arizona, 85259

California Cancer Associates for Research and Excellence
Fresno, California, 93720

Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, 95020

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, 94115

Rocky Mountain Cancer Center
Denver, Colorado, 80218

Yale Cancer Center
New Haven, Connecticut, 06520

Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, 20007

University of Florida Health Davis Cancer Center
Gainesville, Florida, 32610

Ocala Oncology Center
Ocala, Florida, 34471

Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322

The University of Chicago
Chicago, Illinois, 60637

Illinois CancerCare, P.C.
Peoria, Illinois, 61615-7828

Massachusetts General Hospital
Boston, Massachusetts, 02114

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Karmanos Cancer Institute
Detroit, Michigan, 48201

Mayo Clinic
Rochester, Minnesota, 55905

University of Nebraska Medical Center
Omaha, Nebraska, 68198

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901

University of Rochester
Rochester, New York, 14642

Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Gabrail Cancer Center Research
Canton, Ohio, 44718

The Mark H. Zangmeister Center
Columbus, Ohio, 43219

Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, 18512

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232

Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246

Seattle Cancer Care Alliance
Seattle, Washington, 98109

Fox Valley Hematology & Oncology
Appleton, Wisconsin, 54915

Taiho Oncology, Inc.
NCT Number
MeSH Terms
Colorectal Neoplasms