NCT02926222

Regorafenib in Relapsed Glioblastoma

Regorafenib in Relapsed Glioblastoma REGOMA Study Randomized, Controlled Open-label Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib is formulated as tablets of 40mg for oral administration.
DRUG	Lomustine	Lomustine is formulated as tablets of 40mg for oral administration.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2021-06-01
• First posted: 2016-10-06
• Last updated: 2022-09-09

Locations

10 sites across 1 country: Italy