Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218499
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-01-18
Brief Title:
Brightline-1 A Study to Compare Brigimadlin BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Brightline-1 A Phase IIIII Randomized Open-label Multi-center Study of Brigimadlin BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 people with a type of cancer called dedifferentiated liposarcoma People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate
The purpose of this study is to compare a medicine called brigimadlin BI 907828 with doxorubicin in people with liposarcoma Brigimadlin BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer Doxorubicin is a medicine already used to treat cancer including liposarcoma
During the study participants get either brigimadlin BI 907828 or doxorubicin Every 3 weeks participants take brigimadlin BI 907828 as tablets or doxorubicin as an infusion into a vein Participants can switch to brigimadlin BI 907828 treatment if they did not benefit from doxorubicin treatment
Participants can continue treatment in the study as long as they benefit from it and can tolerate it
Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body The doctors also regularly check participants health and take note of any unwanted effects
The purpose of this study is to compare a medicine called brigimadlin BI 907828 with doxorubicin in people with liposarcoma Brigimadlin BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer Doxorubicin is a medicine already used to treat cancer including liposarcoma
During the study participants get either brigimadlin BI 907828 or doxorubicin Every 3 weeks participants take brigimadlin BI 907828 as tablets or doxorubicin as an infusion into a vein Participants can switch to brigimadlin BI 907828 treatment if they did not benefit from doxorubicin treatment
Participants can continue treatment in the study as long as they benefit from it and can tolerate it
Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body The 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 |
|---|---|---|---|
| 2021-002392-20 | EUDRACT_NUMBER | None | None |