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Phase IIb Open-label Trial of SUBA-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)

Trial Profile

Phase IIb Open-label Trial of SUBA-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2019

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At a glance

  • Drugs Itraconazole (Primary)
  • Indications Basal cell cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms SCORING
  • Sponsors HedgePath Pharmaceuticals
  • Most Recent Events

    • 20 Feb 2019 Planned End Date changed from 1 Jun 2019 to 1 Apr 2019.
    • 20 Feb 2019 Planned primary completion date changed from 1 Dec 2018 to 1 Mar 2019.
    • 09 Oct 2018 According to a HedgePath Pharmaceuticals media release, the company must provide an analysis of basal cell carcinoma tumor burden responses via independent analysis of tumor photographs to confirm results reported by the clinical investigators. FDA requested to submit an Integrated Safety Summary (ISS) that includes data from all human trials of SUBA-Itraconazole (the active ingredient in SUBA BCCNS) regardless of strength and indication. Revised anticipated NDA submission date is in 1Q 2019.
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