BI 907828 vs Doxorubicin for Liposarcoma
Recruiting at360 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Boehringer Ingelheim
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
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.Inclusion Criteria
I am over 18, can follow birth control guidelines if needed, and agree to the consent form.
I have a tumor that can be measured by scans.
My pathology report shows a DDLPS diagnosis with positive MDM2.
See 7 more
Exclusion Criteria
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 been treated with anthracyclines before, but any other cancer treatment was over 5 years ago, except hormone therapy.
See 5 more
Treatment Details
Interventions
- BI 907828 (MDM2 Inhibitor)
- Doxorubicin (Anti-tumor antibiotic)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Trials
2,566
Recruited
16,150,000+