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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2018

At a glance

  • Drugs Avasopasem manganese (Primary)
  • Indications Stomatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ROMAN
  • Sponsors Galera Therapeutics
  • Most Recent Events

    • 16 Oct 2018 According to a Galera Therapeutics media release, data of this trial will support the submission of a New Drug Application of GC-4419 to the U.S. Food and Drug Administration
    • 16 Oct 2018 According to a Galera Therapeutics media release, first patient has been dosed. Company anticipate enrollment to take less than two years,
    • 04 Oct 2018 Status changed from not yet recruiting to recruiting.
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