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
Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in
patients with refractory metastatic colorectal cancer.
Detailed Description
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).
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- Has provided written informed consent
- Has adenocarcinoma of the colon or rectum
- Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- 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.
- Certain serious illnesses or medical condition(s)
- 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
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Sites
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California
- LAC and USC Medical Center, Los Angeles, California, 90033
- Coastal Integrative Cancer Care, San Luis Obispo, California, 93401
- California Cancer Associates for Research and Excellence, Fresno, California, 93720
- Ronald H. Yanagihara, MD, Gilroy, California, 95020
- San Jose Medical Group, San Jose, California, 95124
- Pacific Hematology Oncology Associates, San Francisco, California, 94115
-
Arizona
- Arizona Center for Cancer Care, Glendale, Arizona, 85306
-
Missouri
- Saint Luke's Cancer Institute, Kansas City, Missouri, 64111
-
Louisiana
- Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, 70809
-
Illinois
- Illinois Cancer Care, P.C., Peoria, Illinois, 61615
-
Indiana
- Indiana University Simon Cancer Center, Indianapolis, Indiana, 46202
-
Germany
- Universitaetsklinikum Ulm, Ulm, 89081
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Italy
- A.O. R.N. "A.Cardarelli", Naples, 80131
- Seconda Universita degli Studi de Napoli, Napoli, 80131
- Ospedale di Rimini, Rimini, 47923
- Arcispidale S Maria Nuova, Reggio Emilia, 42123
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France
- Centre Oscar Lambret, Lille, 59020
- Hopital Saint Antoine, Paris cedex 12, 75571
- Centre Eugene Marquis, Rennes cedex, 35042
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Sweden
- Akademiska Sjukhuset, Uppsala, 75185
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Czech Republic
- Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove, Hradec Kralove, 50005
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Spain
- Hospital General Universitario de Valencia, Valencia, 46014
- Hospital Universitario Morales Messeguer, Murcia, 30008
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