Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects

Trial Profile

Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2018

At a glance

  • Drugs Transcrocetinate sodium (Primary) ; Temozolomide
  • Indications Glioblastoma
  • Focus Registrational; Therapeutic Use
  • Acronyms INTACT
  • Sponsors Diffusion Pharmaceuticals
  • Most Recent Events

    • 03 Apr 2018 According to a Diffusion Pharmaceuticals media release, eight patients are enrolled in this study. The Data Safety Monitoring Board will examine the results of the TSC dose or another ascending doses form these randomized patients.
    • 29 Jan 2018 According to a Diffusion Pharmaceuticals media release, the first patient has been dosed in this trial.
    • 27 Dec 2017 According to a Diffusion Pharmaceuticals media release, the Company projects that enrollment will be completed by early 2019, with interim safety and efficacy data possible in 2020 and trial completion in 2021. Further site initiation is on-going, with first patient enrollment targeted for January 2018.
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