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Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies

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Trial Profile

Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2022

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At a glance

  • Drugs Tipiracil/trifluridine (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Rectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TERRA
  • Sponsors Taiho Pharmaceutical Company

    • Most Recent Events

    • 02 Jul 2022 Results of a network analysis of data pooled from 3 global (ReDOS, CORRECT, RECOURSE) and 3 Asian (TERRA, Yoshino 2012, and CONCUR) studies assessed the impact of regorafenib dose optimization on clinical outcomes compared to best supportive care and TAS-102 in the treatment of relapsed/refractory metastatic colorectal cancer presented at the 24th World Congress on Gastrointestinal Cancer
    • 06 Sep 2019 According to a Taiho Pharmaceutical media release, based on the data from this trial, the China National Medical Products Administration (NMPA) has approved TAS-102 (trifluridine/tipiracil) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin- and irinotecan-based chemotherapy, in addition, might be treated or not able to be treated by an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
    • 05 Feb 2018 Status changed from active, no longer recruiting to completed.
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