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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of patients with a Dose Limiting Toxicity (DLT)
Timeframe: During dose escalation, the DLT evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)
Number of patients with ≥1 adverse event (AE) using the NCI CTCAE v5.0
Timeframe: evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)
Number of patients discontinuing study treatment due to an AE
Timeframe: evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days)