drugset / Trial / NCT05577416
A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
Phase 0
Completed
14 enrolled
Melbourne Health
Nuvation Bio Inc. · collabWalter and Eliza Hall Institute of Medical Research · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection.
Timeline
- Start
- 2022-10-11
- Primary completion
- 2025-03-26
- Completion
- 2025-03-26
Outcome
Met primary endpoint
paper The primary endpoint showed the feasibility and acceptability of conducting a two-stage perioperative trial. PMID 40841487 ↗
Publications
- Drummond KJ, Spiteri M, Cain SA, Jones J, Shaya S, Topp M, Lu T, Tobler R, Valkovic AL, Moore Z, Fatunla OE, Kriel J, Moffet JJD, McAlpine H, Rosier M, Guan H, Dimou J, Schadewaldt V, Roberts-Thomson S, McArdle D, Lui E, Voelker-Albert M, di Sanzo S, Nijagal B, Narayana VK, Mitchell CB, Vissers JHA, Grimmond S, Rosenthal MA, Palmer LM, Best SA, Freytag S, Whittle JR. Perioperative IDH inhibition in treatment-naive IDH-mutant glioma: a pilot trial. Nat Med. 2025 Oct;31(10):3451-3463. doi: 10.1038/s41591-025-03884-4. Epub 2025 Aug 21.
- Cain SA, Topp M, Rosenthal M, Tobler R, Freytag S, Best SA, Whittle JR, Drummond KJ. A perioperative study of Safusidenib in patients with IDH1-mutated glioma. Future Oncol. 2024;20(33):2533-2545. doi: 10.1080/14796694.2024.2383064. Epub 2024 Aug 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Safusidenib | Small molecule | 250 mg | Oral |