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



Status:Available
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Contact:Taiho Oncology Inc. (For US Inquiries Only)
Email:TaihoUSEAP@taihooncology.com
Phone:855-598-8259

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

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.

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.

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
We found this trial at
33
sites
Scottsdale, Arizona 85259
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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433 Southwest 10th Street
Ocala, Florida 34471
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Ocala, FL
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Appleton, Wisconsin 54915
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Appleton, WI
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Birmingham, Alabama 35223
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Birmingham, AL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Canton, OH
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, OH
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Dallas, TX
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Denver, Colorado 80218
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Denver, CO
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Detroit, Michigan 48201
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Dunmore, PA
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Fresno, CA
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Gainesville, FL
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Gilroy, CA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Peoria, Illinois 61615
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Peoria, IL
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Rochester, Minnesota 55905
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San Francisco, California 94115
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San Francisco, CA
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Washington, District of Columbia 20007
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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