Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Refractory Metastatic Gastric Cancer

In brief

The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

Key facts

Study ID

NCT02500043

Run by

Taiho Oncology, Inc.

People needed

507

Starts

2016-02-24

Expected to finish

2019-12-19

Last updated by the study team

2024-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
• Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
• Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Is able to take medications orally (ie, no feeding tube).
• Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
• Has adequate organ function as defined by protocol defined labs.
• 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.

You may not qualify if…

• Has certain serious illnesses or medical conditions
• 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 previously received TAS-102.
• Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
• Is a pregnant or lactating female.

Where it is running

• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• Los Angeles Cancer Network — Los Angeles, California, United States
• University of Southern California - Keck School of Medicine — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• 21st Century Oncology — Jacksonville, Florida, United States
• Mount Sinai Hospital Medical Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Illinois CancerCare P.C. — Peoria, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Dartmouth-Hitchcock Medical Center (DHMC) — Lebanon, New Hampshire, United States
• Laura & Isaac Perlmutter Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Univeristy of Rochester Medical Center — Rochester, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• University of Pittsburgh Medical Cancer Center — Pittsburgh, Pennsylvania, United States
• Roger Williams Medical Center — Providence, Rhode Island, United States
• Coastal Bend Cancer Center — Corpus Christi, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Gomel Regional Clinical Oncology Dispensary — Homyel, Belarus
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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