Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05512377
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-08-22
Brief Title:
Brightline-2 A Study to Test Whether Brigimadlin BI 907828 Helps People With Cancer in the Biliary Tract Pancreas Lung or Bladder
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Brightline-2 A Phase IIaIIb Open-label Single-arm Multi-centre Trial of BI 907828 Brigimadlin for Treatment of Patients With Locally Advanced Metastatic MDM2 Amplified TP53 Wild-type Biliary Tract Adenocarcinoma Pancreatic Ductal Adenocarcinoma or Other Selected Solid Tumours
Status:
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 adults with advanced cancer in the biliary tract pancreas lung or bladder This is a study for people for whom previous treatment was not successful or no treatment exists
The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract pancreas lung or bladder BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer All participants take BI 907828 as a tablet once every 3 weeks Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it They visit the study site regularly At the study site doctors regularly check the size of the tumour and 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 find out whether a medicine called BI 907828 helps people with cancer in the biliary tract pancreas lung or bladder BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer All participants take BI 907828 as a tablet once every 3 weeks Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it They visit the study site regularly At the study site doctors regularly check the size of the tumour and 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 |
|---|---|---|---|
| 2023-506369-79-00 | OTHER | None | None |
| U1111-1292-3392 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |