Regorafenib in Relapsed Glioblastoma

Summary

This study aims to evaluate the role of Regorafenib in prolonging the overall survival of glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or without bevacizumab.

Timeline

Start

2015-11

Primary completion

2017-07

Completion

2021-06

Outcome

Met primary endpoint

paper Overall survival was significantly improved in the regorafenib group compared with the lomustine group PMID 30522967 ↗

paper hazard ratio 0·50, 95% CI 0·33-0·75; log-rank p=0·0009 PMID 30522967 ↗

Publications

• Lombardi G, Del Bianco P, Brandes AA, Eoli M, Ruda R, Ibrahim T, Lolli I, Rizzato S, Daniele B, Pace A, Pasqualetti F, Caccesse M, Bergo E, Magni G, De Salvo GL, Zagonel V. Patient-reported outcomes in a phase II randomised study of regorafenib compared with lomustine in patients with relapsed glioblastoma (the REGOMA trial). Eur J Cancer. 2021 Sep;155:179-190. doi: 10.1016/j.ejca.2021.06.055. Epub 2021 Aug 10.
• Lombardi G, De Salvo GL, Brandes AA, Eoli M, Ruda R, Faedi M, Lolli I, Pace A, Daniele B, Pasqualetti F, Rizzato S, Bellu L, Pambuku A, Farina M, Magni G, Indraccolo S, Gardiman MP, Soffietti R, Zagonel V. Regorafenib compared with lomustine in patients with relapsed glioblastoma (REGOMA): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2019 Jan;20(1):110-119. doi: 10.1016/S1470-2045(18)30675-2. Epub 2018 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lomustine	Small molecule	110 mg/m2	Oral
Subject	Regorafenib	Small molecule	160 mg	Oral

Indications