Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/8/2017
Start Date:June 17, 2012
End Date:May 23, 2016

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Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in
patients with refractory metastatic colorectal cancer.

This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study
evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory
metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102
(experimental arm) or placebo (control arm).

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
24
sites
1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Ann Arbor, Michigan 48197
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Baton Rouge, Louisiana 70809
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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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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Canton, OH
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Fredericksburg, VA
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Fresno, CA
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Gilroy, California 95020
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Glendale, Arizona 85306
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Indianapolis, Indiana 46202
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Jefferson City, Missouri 65109
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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Kansas City, MO
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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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Los Angeles, California 90033
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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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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 Orleans, Louisiana 70121
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Peoria, Illinois 61656
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San Francisco, California 94115
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San Jose, California
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San Luis Obispo, California 93401
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Sydney, New South Wales 2065
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