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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2018

At a glance

  • Drugs Tipiracil/trifluridine (Primary)
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TAGS
  • Sponsors Taiho Pharmaceutical
  • Most Recent Events

    • 17 Aug 2018 According to a Taiho Pharmaceutical media release, the company applied to the Japanese Ministry of Health, Labour and Welfare for an additional indication for unresectable advanced or recurrent gastric cancer for LONSURF combination tablet T15, T20 (trifluridine and tipiracil), based on results from this trial.
    • 21 Jun 2018 According to a Taiho Pharmaceutical media release, company is intend to include these data in an sNDA submission to the U.S. Food and Drug Administration (FDA) for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer.
    • 21 Jun 2018 According to a Taiho Pharmaceutical media release, data from this trial were presented as oral and poster presentations at the ESMO 20th World Congress on Gastrointestinal Cancer 2018.
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