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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 belowSelect...
My pathology report shows a DDLPS diagnosis with positive MDM2.
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My cancer samples are stored and available for review.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of advanced liposarcoma that cannot be removed by surgery.
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I am willing to have a tumor biopsy as required.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
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 moreTrial 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
2,515 Previous Clinical Trials
11,346,888 Total Patients Enrolled
2 Trials studying Liposarcoma
1,630 Patients Enrolled for Liposarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, can follow birth control guidelines if needed, and agree to the consent form.I have received treatment for liposarcoma before.I have had cancer other than DDLPS or WDLPS in the last 5 years, but it was treated and considered cured.I have a tumor that can be measured by scans.I have been treated with anthracyclines before, but any other cancer treatment was over 5 years ago, except hormone therapy.My pathology report shows a DDLPS diagnosis with positive MDM2.My organs are working well.My cancer samples are stored and available for review.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is a type of advanced liposarcoma that cannot be removed by surgery.I have signed and understand the consent form for this trial.I have a known TP53 gene mutation.I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.I am not taking any medication that could interfere with the trial's safety.I am willing to have a tumor biopsy as required.I am willing to give blood samples for research on my cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Brigimadlin (BI 907828) high dose
- Group 2: Brigimadlin (BI 907828) low dose
- Group 3: Brigimadlin (BI 907828) arm
- Group 4: Doxorubicin arm
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.
Liposarcoma Patient Testimony for trial: Trial Name: NCT05218499 — Phase 2 & 3
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