Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619509
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Single-arm Open-label Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults who participated in a previous clinical study with brigimadlin
The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer
Participants are grouped in cohorts depending on their treatment in the previous study
Cohort 1a got brigimadlin and continues treatment with brigimadlin
Cohort 1b got brigimadlin for 4 or less treatment cycles each cycle was 3 weeks long
Cohort 2 received a comparator and gets brigimadlin for the first time
All participants take brigimadlin as tablets once every 3 weeks at the study site Participants in the Cohorts 1b and 2 visit the sites more frequently At study visits doctors check participants health and take note of any unwanted effects At some study visits doctors also check the size of the tumour and whether it has spread to other parts of the body
Participants are in the study as long as they benefit from treatment and can tolerate it
The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer
Participants are grouped in cohorts depending on their treatment in the previous study
Cohort 1a got brigimadlin and continues treatment with brigimadlin
Cohort 1b got brigimadlin for 4 or less treatment cycles each cycle was 3 weeks long
Cohort 2 received a comparator and gets brigimadlin for the first time
All participants take brigimadlin as tablets once every 3 weeks at the study site Participants in the Cohorts 1b and 2 visit the sites more frequently At study visits doctors check participants health and take note of any unwanted effects At some study visits doctors also check the size of the tumour and whether it has spread to other parts of the body
Participants are in the study as long as they benefit from treatment and can tolerate it
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None