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
Latest Information Update: 21 Mar 2025
At a glance
- Drugs AZD 1390 (Primary)
- Indications Glioblastoma; Glioma
- Focus Pharmacokinetics; Therapeutic Use
- Acronyms WITHDAWN
- 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.