Olaparib in Recurrent IDH-mutant Glioma

Phase 2 Completed 35 enrolled Hospices Civils de Lyon

NaSingle-groupOpen-labelTreatment

Summary

Recent data demonstrate that in IDH-mutant gliomas, 2 hydroxy-glutarate production induces a homologous recombination defect that renders tumor cells exquisitely sensitive to poly(adenosine 5'-diphosphate-ribose) polymerase (PARP) inhibitors, including olaparib (Lynparza; AstraZeneca). The aim of this open-label phase 2 study is to evaluate the efficacy of olaparib in in recurrent IDH-mutant high grade gliomas based on 6 months progression-free survival.

Timeline

Start: 2019-03-20
Primary completion: 2021-11-08
Completion: 2021-11-24

Outcome

Missed primary endpoint

paper Although it did not meet its primary endpoint PMID 38855053 ↗

Publications

Results Esparragosa Vazquez I, Sanson M, Chinot OL, Fontanilles M, Rivoirard R, Thomas-Maisonneuve L, Cartalat S, Tabouret E, Appay R, Bonneville-Levard A, Darlix A, Meyronet D, Barritault M, Gueyffier F, Remontet L, Maucort-Boulch D, Honnorat J, Dehais C, Ducray F; POLA Network. Olaparib in recurrent isocitrate dehydrogenase mutant high-grade glioma: A phase 2 multicenter study of the POLA Network. Neurooncol Adv. 2024 May 27;6(1):vdae078. doi: 10.1093/noajnl/vdae078. eCollection 2024 Jan-Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olaparib	Small molecule	300 mg	Oral