Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04121455
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2019-09-25
Brief Title:
Glioblastoma Treatment With Irradiation and Olaptesed Pegol NOX-A12 in MGMT Unmethylated Patients
Sponsor:
TME Pharma AG
Organization:
TME Pharma AG
Study Overview
Official Title:
Single-arm Dose-escalation Phase 12 Study of Olaptesed Pegol NOX-A12 in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group
Status:
ACTIVE_NOT_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:
GLORIA
Brief Summary:
The purpose of this study is to obtain first exploratory information on the safety and efficacy of i olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection biopsy only or after incomplete tumor resection and ii olaptesed pegol in combination with radiation therapy and bevacizumab in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection biopsy only or after incomplete or complete tumor resection
Further arms are included i to establish safety for the combination of olaptesed pegol at three different doses in addition to radiotherapy and bevacizumab ii to explore the benefit of combining olaptesed pegol at different dose levels with bevacizumab in order to define the doses to move forward into a subsequent randomized dose-finding study iii to explore the contribution of the therapy components olaptesed pegol and bevacizumab to patient benefit and iv to put the clinical outcome of these treatment regimens into perspective with the standard of care treatment with temozolomide and radiotherapy
Further arms are included i to establish safety for the combination of olaptesed pegol at three different doses in addition to radiotherapy and bevacizumab ii to explore the benefit of combining olaptesed pegol at different dose levels with bevacizumab in order to define the doses to move forward into a subsequent randomized dose-finding study iii to explore the contribution of the therapy components olaptesed pegol and bevacizumab to patient benefit and iv to put the clinical outcome of these treatment regimens into perspective with the standard of care treatment with temozolomide and radiotherapy
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-004064-62 | EUDRACT_NUMBER | None | None |