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A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 18 May 2023

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At a glance

  • Drugs Donafenib (Primary)
  • Indications Thyroid cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DTC
  • Sponsors Suzhou Zelgen Biopharmaceuticals

    • Most Recent Events

    • 15 May 2023 Primary endpoint (Progression Free Survival (PFS) has been met according to Results published in the Clinical Cancer Research.
    • 15 May 2023 Results assessing the antitumour activity and safety of donafenib in Chinese RAIR-DTC patients published in the Clinical Cancer Research
    • 29 Nov 2021 Status changed from recruiting to discontinued, based on IDMC's recommendations during the interim analysis"the trial has reached the goal of early termination of the trial",the sponsor communicating with CDE,CDE agreed to unblind the trial and submit a NDA.
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