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

Trial Status: Complete

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.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: COMPLETED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: COMPLETED

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: COMPLETED

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: COMPLETED

This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study

evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in

participants with metastatic gastric cancer who have previously received at least 2 prior

regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to

TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Taiho Pharmaceutical Company Limited

  • Primary ID TO-TAS-102-302
  • Secondary IDs NCI-2016-00338, 2015-002683-16, s15-01245
  • Clinicaltrials.gov ID NCT02500043