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

Brief 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 patients with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible patients will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date: December 2015
Estimated Primary Completion Date: June 2018
Estimated Study Completion Date: December 2018

Arm:
- Experimental: TAS-102
- Experimental: Placebo