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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
Must not have
Known mutation in the TP53 gene (screening for TP53 status is not required)
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights
Summary
This trial is for adults with advanced dedifferentiated liposarcoma who are not receiving other treatments. It compares a new drug, brigimadlin (BI 907828), which blocks a protein that helps cancer grow, with doxorubicin, an existing drug that damages cancer cell DNA. Participants receive either brigimadlin as tablets or doxorubicin through a vein. Doctors monitor tumor size and health regularly. The new drug aims to be effective and less toxic compared to conventional treatments.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known TP53 gene mutation.
Select...
I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.
Select...
I am not taking any medication that could interfere with the trial's safety.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival
Secondary study objectives
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
+5 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Liposarcoma treatments often target specific cellular mechanisms to inhibit tumor growth. Brigimadlin (BI 907828) is an MDM2 inhibitor that works by blocking the MDM2 protein, which normally inhibits the tumor suppressor p53.
By inhibiting MDM2, p53 activity is restored, leading to increased cancer cell death. Doxorubicin, a widely used chemotherapy agent, intercalates DNA and inhibits topoisomerase II, preventing DNA replication and leading to cell death.
Eribulin inhibits microtubule dynamics, disrupting mitotic spindle formation and causing cell cycle arrest. Gemcitabine, often combined with other agents like docetaxel, is a nucleoside analog that incorporates into DNA, causing chain termination and apoptosis.
These mechanisms are crucial for liposarcoma patients as they target the cancer cells' ability to proliferate and survive, offering potential therapeutic benefits.
Effect of matrix metalloproteinase inhibitor batimastat on breast cancer regrowth and metastasis in athymic mice.Therapeutic effects of the novel Leucyl-tRNA synthetase inhibitor BC-LI-0186 in non-small cell lung cancer.Sporadic Angiomyolipomas Growth Kinetics While on Everolimus: Results of a Phase II Trial.
Effect of matrix metalloproteinase inhibitor batimastat on breast cancer regrowth and metastasis in athymic mice.Therapeutic effects of the novel Leucyl-tRNA synthetase inhibitor BC-LI-0186 in non-small cell lung cancer.Sporadic Angiomyolipomas Growth Kinetics While on Everolimus: Results of a Phase II Trial.
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,379,741 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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