drugset

drugset / Trial / NCT03643549

Bortezomib and Temozolomide in Recurrent Grade-4 Glioma Unmethylated MGMT Promoter (BORTEM-17)

NCT03643549 ↗

Phase 1/2 Unknown 63 enrolled Haukeland University Hospital Oslo University Hospital · collab St. Olavs Hospital · collab University Hospital of North Norway · collab University of Bergen · collab University of Bonn · collab University of Oslo · collab

NaSequentialOpen-labelTreatment

Summary

This phase IB/II trial is designed to investigate the safety and survival benefits for patients with recurrent grade-4 with unmethylated MGMT promoter treated with Bortezomib and Temozolomide in a specific schedule.

Timeline

Start: 2018-08-30
Primary completion: 2025-06-30
Completion: 2025-12-31

Publications

Rahman MA, Brekke J, Arnesen V, Hannisdal MH, Navarro AG, Waha A, Herfindal L, Rygh CB, Bratland E, Brandal P, Haasz J, Oltedal L, Miletic H, Lundervold A, Lie SA, Goplen D, Chekenya M. Sequential bortezomib and temozolomide treatment promotes immunological responses in glioblastoma patients with positive clinical outcomes: A phase 1B study. Immun Inflamm Dis. 2020 Sep;8(3):342-359. doi: 10.1002/iid3.315. Epub 2020 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Subject	Temozolomide	Small molecule	150 mg/m2	Oral
Subject	Temozolomide	Small molecule	175 mg/m2	Oral
Subject	Temozolomide	Small molecule	200 mg/m2	Oral

Indications