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MDM2 Inhibitor
Brigimadlin + Radiation for Glioblastoma
Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically (if prior biopsy) or radiologically diagnosed glioblastoma
Eligible for neurosurgical tumor resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months.
Awards & highlights
Study Summary
This trial is for a new cancer drug that is taken before surgery to remove a brain tumor. Part one is to see how well the drug is taken up by the tumor and part two is to see what the highest dose is that patients can tolerate in combination with standard radiation therapy.
Who is the study for?
Adults with newly diagnosed glioblastoma, a type of brain tumor. Part 1 is for those awaiting surgery; Part 2 for post-surgery patients eligible for radiation therapy. Must be over 18, have good performance status (0 or 1), and stable health on certain medications. Excludes those with specific genetic mutations, prior systemic therapy/radiotherapy (except Phase 0 participants), poor kidney function, or incompatible implants.Check my eligibility
What is being tested?
The study tests BI 907828 (Brigimadlin), an MDM2 inhibitor cancer drug. Part 1 assesses how the drug accumulates in the tumor after one dose before surgery. In Part 2, the highest tolerable dose is sought alongside standard radiation therapy over six weeks with regular visits and potential continuation if beneficial.See study design
What are the potential side effects?
While not explicitly listed in the provided information, side effects may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes and increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of glioblastoma was confirmed through a biopsy or imaging tests.
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I am a candidate for surgery to remove a brain tumor.
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I am 18 years old or older.
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My glioblastoma is TP53 wild type and has unmethylated MGMT promoters.
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I have had surgery to remove a brain tumor and can undergo standard radiotherapy.
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I have been diagnosed with glioblastoma through a biopsy or imaging tests.
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I am a candidate for surgery to remove a brain tumor.
Select...
I am 18 years old or older.
Select...
My glioblastoma is TP53 wild type and has unmethylated MGMT promoters.
Select...
I had surgery to remove a brain tumor and can have standard radiotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 0: Calculated unbound concentration of BI 907828 (Brigimadlin) in brain tissue homogenate from noncontrast enhancing and contrast enhancing brain tumor regions
Phase 0: Measured total concentration of BI 907828 (Brigimadlin) in brain tissue homogenate from noncontrast enhancing and contrast enhancing brain tumor regions
Phase Ia: Occurrence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 during the entire treatment period
+1 moreSecondary outcome measures
Phase 0: Dose-dependent changes of expression levels of Tumor suppressor protein p53 (TP53) target genes in contrast enhancing brain regions and non-contrast enhancing brain regions
Phase Ia: Area under the Curve of BI 907828 (Brigimadlin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Phase Ia: Area under the Curve of BI 907828 (Brigimadlin) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase Ia Part: BI 907828 (Brigimadlin)Experimental Treatment1 Intervention
Group II: Phase 0 Part: BI 907828 (Brigimadlin)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,539 Total Patients Enrolled
3 Trials studying Glioblastoma
98 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a candidate for surgery to remove a brain tumor.My grade IV astrocytoma is IDH mutant.I have had treatment for glioblastoma, but not in a Phase 0 trial.I cannot have an MRI due to kidney issues or metal implants.I had surgery to remove a brain tumor and can have standard radiotherapy.My glioblastoma is TP53 wild type and has unmethylated MGMT promoters.My neurological condition is stable, and I've been on a steady or decreasing dose of my medication for the past week.My diagnosis of glioblastoma was confirmed through a biopsy or imaging tests.I am 18 years old or older.I am mostly active and can care for myself, despite my illness.I have had surgery to remove a brain tumor and can undergo standard radiotherapy.My glioblastoma is known to have a TP53 mutation.I have been diagnosed with glioblastoma through a biopsy or imaging tests.I must take or plan to take certain restricted medications.I cannot have an MRI due to kidney issues or metal implants.I am not taking any medication that could interfere with the trial.I am a candidate for surgery to remove a brain tumor.I am 18 years old or older.I am mostly active and can care for myself, despite my illness.My glioblastoma is TP53 wild type and has unmethylated MGMT promoters.My neurological condition is stable, and I've been on a steady or decreasing dose of my medication for at least a week.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ia Part: BI 907828 (Brigimadlin)
- Group 2: Phase 0 Part: BI 907828 (Brigimadlin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participation rate of this experiment?
"In order to commence the trial, 35 eligible patients must be recruited. The sponsor of this experiment is Boehringer Ingelheim and they have picked two sites for their operations: Mayo Clinic Cancer Center in Jacksonville, Florida and Mayo Clinic-Arizona in Phoenix, Arizona."
Answered by AI
Has BI 907828 been given the go-ahead by the FDA?
"Due to the fact that it is currently in its Phase 1 trial, BI 907828 has been assessed a score of 1 on our safety scale. This means there is limited evidence to support both efficacy and security."
Answered by AI
Are there open opportunities for patients to enroll in this experiment?
"As stated on clinicaltrials.gov, this medical study is actively recruiting participants. The original posting was made on July 28th 2022 with the last update being November 14th of the same year."
Answered by AI
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