← Back to Search

MDM2 Inhibitor

BI 907828 vs Doxorubicin for Liposarcoma

Phase 2 & 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available
Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights

Study Summary

This trial is comparing two treatments for dedifferentiated liposarcoma- BI 907828 and doxorubicin.

Who is the study for?
Adults with a specific cancer called dedifferentiated liposarcoma, who haven't had systemic therapy for it, can join this trial. They must have measurable tumor growth and be in good health otherwise. Women of childbearing age and men must use effective birth control.Check my eligibility
What is being tested?
The trial compares BI 907828, an MDM2 inhibitor pill taken every three weeks, against doxorubicin, a standard cancer infusion treatment. Participants may switch to BI 907828 if doxorubicin isn't helping them.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer medications such as nausea, fatigue, hair loss (with doxorubicin), and potential blood cell count changes. Specific side effects of BI 907828 are not detailed but could resemble other chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pathology report shows a DDLPS diagnosis with positive MDM2.
Select...
My cancer samples are stored and available for review.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is a type of advanced liposarcoma that cannot be removed by surgery.
Select...
I am willing to have a tumor biopsy as required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level)
Change from baseline in QLQ-C30 (Quality of Life questionnaire C30)
Change from baseline in fatigue
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Brigimadlin (BI 907828) low doseExperimental Treatment1 Intervention
Phase II
Group II: Brigimadlin (BI 907828) high doseExperimental Treatment1 Intervention
Phase II
Group III: Brigimadlin (BI 907828) armExperimental Treatment1 Intervention
Phase III
Group IV: Doxorubicin armActive Control1 Intervention
Phase II/III

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
10,916,472 Total Patients Enrolled
2 Trials studying Liposarcoma
1,640 Patients Enrolled for Liposarcoma

Media Library

BI 907828 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05218499 — Phase 2 & 3
Liposarcoma Research Study Groups: Brigimadlin (BI 907828) high dose, Brigimadlin (BI 907828) arm, Brigimadlin (BI 907828) low dose, Doxorubicin arm
Liposarcoma Clinical Trial 2023: BI 907828 Highlights & Side Effects. Trial Name: NCT05218499 — Phase 2 & 3
BI 907828 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05218499 — Phase 2 & 3
Liposarcoma Patient Testimony for trial: Trial Name: NCT05218499 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical research facilities is this experiment being conducted today?

"38 hospitals and clinics are currently running this study. If you choose to participate in the trial, it is important to select a location near to reduce the travel burden."

Answered by AI

Are investigators currently looking for more participants?

"From what is displayed on clinicaltrials.gov, it appears as though this trial is still looking for volunteers. The listing was published on March 25th, 2022 and the most recent update was November 2nd of the same year."

Answered by AI

How many willing participants are needed for this clinical trial?

"In order to properly run this trial, 300 individuals that meet the necessary requirements must be recruited. The sponsor company, Boehringer Ingelheim, will manage the study from various hospitals including Oregon Health and Sciences University in Portland, Oregon as well as The Ottawa Hospital located in Ottawa, Ontario."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Fred Hutchinson Cancer Research Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have peritoneal lyposarcoma and had it remove 2 years ago. It returned and I finished eradication 4 weeks ago. I was told this week they cannot remove it surgically and I am looking for drug options . Please contact me immediately as it is time sensitive.
PatientReceived 2+ prior treatments
~0 spots leftby Apr 2024