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Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients — REGOMA-2  

Glioblastoma, IDH-wildtype Clinical Trial

Official title:
Regorafenib in Combination With Temozolomide With or Without Radiotherapy in Patients With Newly Diagnosed MGMT-Methylated, IDH Wild-type Glioblastoma. A Phase I Dose-finding Study

Clinical Trial Summary

This study will evaluate the addition of regorafenib to standard of care treatment with TMZ as adjuvant therapy, and in combination with TMZ+RT as concomitant therapy. The standard of care for newly diagnosed GBM (ndGBM) includes surgical resection to the extent that is safely feasible, followed by RT plus concomitant TMZ chemotherapy, and up to 6 months of adjuvant TMZ. The dose escalation will be explored following a "3+3" design, escalating oral doses of regorafenib in combination with adjuvant (maintenance) TMZ (cohort A) to estimate the MTD of regorafenib as adjuvant (maintenance) therapy. After finding the MTD in the Adjuvant Therapy dose escalation, the Concomitant Therapy (cohort B) dose escalation will start, exploring escalating oral doses of regorafenib in combination with concomitant TMZ+RT, to estimate the MTD of regorafenib as concomitant therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06095375
Study type Interventional
Source Istituto Oncologico Veneto IRCCS
Contact Gian Luca De Salvo, MD
Phone 00390498215704
Email clinical.trial@iov.veneto.it
Status Recruiting
Phase Phase 1
Start date July 4, 2022
Completion date December 2025
View Details
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