At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 507 enrolled
Drug / intervention
TAS-102 +1 moredrug
Likely dose
TAS-102 35 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating TAS-102 and Placebo for Refractory Metastatic Gastric Cancer. Completed, enrolled 507 participants across 139 sites in 18 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Metastatic Gastric Cancer
CountriesBelarus, Belgium, Canada, Czechia, France, Germany, Ireland, Israel, Italy, Japan, Poland, Portugal, Romania, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartFeb 2016
Primary CompletionApr 2018
Study CompletionDec 2019
TodayJul 2026
First PostedJul 16, 2015
Enrollment StartFeb 24, 2016
Primary CompletionApr 30, 2018
Study CompletionDec 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.0 years ago
Interventions
TAS-102drug
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Placebodrug
35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.