Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05613036
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-11-03
Brief Title:
A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-label Non-randomized Phase I Investigation of Human ADME Absorption Distribution Metabolism and Excretion and Absolute Oral Bioavailability of BI 907828 in Patients With Advanced Solid Tumours
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:
None
Brief Summary:
This study is open to adults with advanced cancer solid tumours People for whom previous treatment was not successful or no treatment exists can take part This study tests a medicine called BI 907828 BI 907828 is a so-called p53-MDM2 antagonist that is being developed to treat cancer
The purpose of the study is to find out how BI 907828 is processed in the body In the first 3 weeks participants therefore get a single dose of BI 907828 in a labelled form The first participants take BI 907828 as a liquid This is to find out how much BI 907828 is taken up in the body when it is taken by mouth Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet This is to find out how long BI 907828 stays in the blood After the first 3 weeks all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it
During the study participants visit the study site regularly Some of the study visits include staying overnight At the beginning some of the participants stay at the study site for 15 nights The doctors also regularly check participants health and take note of any unwanted effects
The purpose of the study is to find out how BI 907828 is processed in the body In the first 3 weeks participants therefore get a single dose of BI 907828 in a labelled form The first participants take BI 907828 as a liquid This is to find out how much BI 907828 is taken up in the body when it is taken by mouth Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet This is to find out how long BI 907828 stays in the blood After the first 3 weeks all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it
During the study participants visit the study site regularly Some of the study visits include staying overnight At the beginning some of the participants stay at the study site for 15 nights 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?:
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 |
|---|---|---|---|
| 2021-006682-38 | EUDRACT_NUMBER | None | None |