Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03449381
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2018-02-12
Brief Title:
This Study Aims to Find the Best Dose of BI 907828 Brigimadlin in Patients With Different Types of Advanced Cancer Solid Tumors
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase IaIb Open Label Multicenter Dose-escalation Study of BI 907828 Brigimadlin in Patients With Advanced or Metastatic Solid Tumors
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 adults with different types of advanced cancer solid tumors The purpose of this study is to find out the most suitable dose of BI 907828 brigimadlin the participants can tolerate The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink
In this study brigimadlin is given to humans for the first time Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer Brigimadlin is taken as a tablet Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks
The participants are in the study for as long as they benefit from and can tolerate treatment The doctors regularly check the participants general health during the study
In this study brigimadlin is given to humans for the first time Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer Brigimadlin is taken as a tablet Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks
The participants are in the study for as long as they benefit from and can tolerate treatment The doctors regularly check the participants general health during the study
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 |
|---|---|---|---|
| 2017-003210-95 | EUDRACT_NUMBER | None | None |