← Back to Search

MDM2 Inhibitor

Brigimadlin treatment for Liposarcoma

Phase 3

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)

Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 23 months

Awards & highlights

Study Summary

This trial is for adults with a specific type of cancer called dedifferentiated liposarcoma. The purpose of the trial is to see if a medicine called brigimadlin can help people with

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Specific side effects aren't listed here but generally include any unwanted symptoms or medical conditions that occur while taking Brigimadlin. These are monitored closely by healthcare professionals throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not had any treatment for DDLPS in any form.

Select...

I have had treatment for DDLPS before, in any form.

Select...

My report shows I have DDLPS with a positive MDM2 test.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 23 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 23 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 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

Occurrence of TEAEs with Grade ≥3 according to CTCAE version 5 during the entire treatment period

Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period

Secondary outcome measures

Disease control (DC)

Duration of objective response (DOR)

Objective response (OR)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Brigimadlin treatmentExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,667 Total Patients Enrolled

2 Trials studying Liposarcoma

1,800 Patients Enrolled for Liposarcoma

Frequently Asked Questions

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

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the details provided on clinicaltrials.gov indicate that this trial is actively seeking participants. The study was initially posted on December 12th, 2023 and underwent its latest update on December 14th, 2023. With an aim to enroll a total of 240 patients, recruitment will take place across three distinct locations."

Answered by AI

What is the current number of individuals being recruited for participation in this medical research study?

"Indeed, the information available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on December 12th, 2023 and it was last edited on December 14th, 2023. A total of 240 individuals will be enrolled in this study across three designated sites."

Answered by AI

Has the medication Brigimadlin received official approval from the FDA for its therapeutic use?

"Based on the fact that this trial is in Phase 3, indicating a substantial amount of safety data and some evidence of efficacy, our team at Power rates the safety of Brigimadlin treatment as a 3."

Answered by AI