NCT02500043

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Refractory Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	TAS-102	35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
DRUG	Placebo	35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

Timeline

• Start date: 2016-02-24
• Primary completion: 2018-04-30
• Completion: 2019-12-19
• First posted: 2015-07-16
• Last updated: 2024-09-03
• Results posted: 2021-09-16

Locations

139 sites across 18 countries: United States, Belarus, Belgium, Canada, Czechia, France, Germany, Ireland, Israel, Italy, Japan, Poland, Portugal, Romania, Russia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study