Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05376800
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-05-03
Brief Title:
A Study to Determine How BI 907828 Brigimadlin is Taken up in the Tumor Phase 0 and to Determine the Highest Dose of BI 907828 Brigimadlin That Could be Tolerated Phase 1a in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase 0Ia Study of BI 907828 Brigimadlin Concentrations in Brain Tissue and a Non-randomized Open-label Dose Escalation Study of BI 907828 Brigimadlin in Combination With Radiotherapy in Patients With Newly Diagnosed Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This study is open to adults with newly diagnosed glioblastoma a type of brain tumor The study has two parts Part 1 is open to people who can get their brain tumor removed by surgery Part 2 is open to people who already had such a brain surgery
This study tests a medicine called BI 907828 Brigimadlin BI 907828 Brigimadlin is a socalled MDM2 inhibitor that is being developed to treat cancer
The purpose of Part 1 of the study is to find out how BI 907828 Brigimadlin is taken up in the tumor Participants take a single dose of BI 907828 Brigimadlin as a tablet before the brain surgery Part 1 of the study takes about 1 month During this time participants have their brain tumor removed by surgery and visit the study site about 8 times
The purpose of Part 2 is to find the highest dose of BI 907828 Brigimadlin that the participants can tolerate in combination with standard radiation therapy During the first 6 weeks participants get standard radiation therapy In addition they take a dose of BI 907828 Brigimadlin once every 3 weeks Participants may continue to take BI 907828 Brigimadlin as long as they benefit from treatment and can tolerate it They visit the study site regularly
During the entire study doctors also regularly check participants health and take note of any unwanted effects
This study tests a medicine called BI 907828 Brigimadlin BI 907828 Brigimadlin is a socalled MDM2 inhibitor that is being developed to treat cancer
The purpose of Part 1 of the study is to find out how BI 907828 Brigimadlin is taken up in the tumor Participants take a single dose of BI 907828 Brigimadlin as a tablet before the brain surgery Part 1 of the study takes about 1 month During this time participants have their brain tumor removed by surgery and visit the study site about 8 times
The purpose of Part 2 is to find the highest dose of BI 907828 Brigimadlin that the participants can tolerate in combination with standard radiation therapy During the first 6 weeks participants get standard radiation therapy In addition they take a dose of BI 907828 Brigimadlin once every 3 weeks Participants may continue to take BI 907828 Brigimadlin as long as they benefit from treatment and can tolerate it They visit the study site regularly
During the entire study doctors also regularly check participants health and take note of any unwanted effects
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 |
|---|---|---|---|
| 2021-005737-17 | EUDRACT_NUMBER | CTIS | None |
| 2023-506409-20-00 | OTHER | None | None |