Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095375
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-03-10
Brief Title:
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated IDH Wild-type GBM Patients
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REGOMA-2
Brief Summary:
This study will evaluate the addition of regorafenib to standard of care treatment with TMZ as adjuvant therapy and in combination with TMZRT 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 33 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 TMZRT to estimate the MTD of regorafenib 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 33 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 TMZRT to estimate the MTD of regorafenib as concomitant therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001604-15 | EUDRACT_NUMBER | None | None |