Regorafenib in Relapsed Glioblastoma

NCT ID: NCT02926222


Title
Regorafenib in Relapsed Glioblastoma REGOMA Study Randomized, Controlled Open-label Phase II Clinical Trial
Purpose
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.
Details
The primary aim of the study is to evaluate the overall survival (OS) in the intention to treat (ITT) population. Secondary aims are to evaluate the progression free survival (PFS), safety, objective response rate (ORR), disease control rate (DCR) in the ITT population, and the evaluation of quality of life (QoL). Additional exploratory objectives include the analysis of antiangiogenic and metabolic biomarkers in tissue at first and second surgery (if performed) by the evaluation of certain metabolic features of tumors that could be involved in tumor responses to antiangiogenic drugs.
Conditions
Glioblastoma Multiforme
Keywords
Source
Istituto Oncologico Veneto IRCCS
Sponsors
Istituto Oncologico Veneto IRCCS, BAYER S.p.A. - Italia
Status
Recruiting
Acronym
REGOMA
Last Updated
04 Oct 2016
URL
Official Link
Locations
Italy