Phase 1Completed
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients (REGOMA-2)
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
- Sponsor
- Istituto Oncologico Veneto IRCCS (Academic or other)
- Enrollment
- 21 enrolled
- Conditions
- Glioblastoma, IDH-wildtype; MGMT-Methylated Glioblastoma
- Interventions
- Regorafenib; Temozolomide
- Ages
- adults, older adults
- Registry
- NCT06095375, EUCTR2021-001604-15
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of patients with a Dose Limiting Toxicity (DLT)
- Number of patients with ≥1 adverse event (AE) using the NCI CTCAE v5.0
- Number of patients discontinuing study treatment due to an AE
History
Last registry update
Study completion
Primary completion
Registered
Started