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A Phase 0/1b, Single Center, Clinical Trial with an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

Trial Profile

A Phase 0/1b, Single Center, Clinical Trial with an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients

Status: Recruiting
Phase of Trial: Phase 0

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs AZD 1390 (Primary)
  • Indications Glioblastoma; Glioma
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms WITHDAWN
  • Most Recent Events

    • 14 Mar 2025 Timeframe for both primary endpoints has been charged. for Phase 0 primary endpoint, timeframe changed from Day 4 Intraoperative to Phase 0 Intraoperative. For Phase 1b primary endpoint it is changed from '6 month progression-free survival (PFS6) rate measured from the time of surgery to date of recurrence' to 'from the date of Phase 0 surgery to the date of progression'.
    • 14 Mar 2025 Planned End Date changed from 1 Jan 2025 to 1 Sep 2027.
    • 14 Mar 2025 Planned primary completion date changed from 1 Jul 2024 to 1 Sep 2025.

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