Skip to main content

A Phase 0/Ia Study of BI 907828 (Brigimadlin) Concentrations in Brain Tissue and a Non-randomized Open-label, Dose Escalation Study of BI 907828 (Brigimadlin) in Combination With Radiotherapy in Patients With Newly Diagnosed Glioblastoma

  • NCT05376800
  • PHASE1
  • INTERVENTIONAL

Last updated: 2024-08-06

Purpose of  Trial

This study is open to adults with newly diagnosed glioblastoma, a type of brain tumor. The study has two parts. Part 1 is open to people who can get their brain tumor removed by surgery. Part 2 is open to people who already had such a brain surgery.

This study tests a medicine called BI 907828 (Brigimadlin). BI 907828 (Brigimadlin) is a socalled MDM2 inhibitor that is being developed to treat cancer.

The purpose of Part 1 of the study is to find out how BI 907828 (Brigimadlin) is taken up in the tumor. Participants take a single dose of BI 907828 (Brigimadlin) as a tablet before the brain surgery. Part 1 of the study takes about 1 month. During this time, participants have their brain tumor removed by surgery and visit the study site about 8 times.

The purpose of Part 2 is to find the highest dose of BI 907828 (Brigimadlin) that the participants can tolerate in combination with standard radiation therapy. During the first 6 weeks, participants get standard radiation therapy. In addition, they take a dose of BI 907828 (Brigimadlin) once every 3 weeks. Participants may continue to take BI 907828 (Brigimadlin) as long as they benefit from treatment and can tolerate it. They visit the study site regularly.

During the entire study, doctors also regularly check participants' health and take note of any unwanted effects.


This study is for people with

Glioblastoma


Interventions being studied

BI 907828 (Brigimadlin)

Register to Save
ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

4 Locations
Phoenix

Mayo Clinic-Arizona


Arizona, 85054, United States
New Haven

Yale New Haven Hospital


Connecticut, 06510, United States
Jacksonville

Mayo Clinic Cancer Center


Florida, 32224, United States
Rochester

Mayo Clinic, Rochester


Minnesota, 55905, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

Back to Results New Search