Brigimadlin for Liposarcoma

Recruiting in Palo Alto (17 mi)

+71 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.

Research Team

Eligibility Criteria

Adults with a specific cancer called dedifferentiated liposarcoma (DDLPS) that tests positive for MDM2 can join this study. They must not have had prior systemic therapy for DDLPS, be able to use effective birth control, and have a life expectancy of at least 3 months. Participants need to be in fairly good health (ECOG status of 0 or 1) and over the age of 18.

Inclusion Criteria

I have at least one tumor that can be measured for treatment response.

You must provide a signed and dated written consent form compliant with ICH-GCP guidelines and local laws prior to participating in any study activities.

I am 18 years old or older.

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Treatment Details

Interventions

Brigimadlin (MDM2 Inhibitor)

Trial OverviewThe trial is testing Brigimadlin, an MDM2 inhibitor cancer drug. Patients will take it as a tablet every three weeks and continue if they benefit without severe side effects. Their health, tumour size, and any unwanted effects are checked regularly by doctors at the study site.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Brigimadlin treatmentExperimental Treatment1 Intervention