Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765812
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-02-15
Brief Title:
A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Sponsor:
Debiopharm International SA
Organization:
Debiopharm International SA
Study Overview
Official Title:
A Phase 12 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The primary purpose of the Phase 1 Dose Escalation of this study is to identify the dose-limiting toxicities DLTs of Debio 0123 combined with temozolomide TMZ Arm A and with TMZ and radiotherapy RT Arms B and C and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma GBM Arm B which was previously added to the protocol has been permanently halted per the safety monitoring committees decision on the safety findings of this arm
The primary purpose of Phase 1 Dose expansion of the study is to assess the doses studied under Phase 1 Dose Escalation Arm A and identify the recommended dose RD for further development
The Phase 2 will start once the RD Phase 1 has been defined The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ compared to the standard of care SOC in adult participants with GBM
The primary purpose of Phase 1 Dose expansion of the study is to assess the doses studied under Phase 1 Dose Escalation Arm A and identify the recommended dose RD for further development
The Phase 2 will start once the RD Phase 1 has been defined The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ compared to the standard of care SOC in adult participants with GBM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1283-6423 | OTHER | UTN Number World Health Organization | None |
| 2022-502156-31 | EUDRACT_NUMBER | None | None |