Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called dedifferentiated liposarcoma, which is an advanced form of cancer that develops in fat cells. The study aims to compare the effectiveness of a new treatment called brigimadlin (BI 907828) with an existing chemotherapy drug known as doxorubicin. Brigimadlin is taken as a film-coated tablet, while doxorubicin is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to determine if brigimadlin is more effective than doxorubicin as a first-line treatment for patients with advanced or metastatic dedifferentiated liposarcoma. Participants in the study will be randomly assigned to receive either brigimadlin or doxorubicin. The study will monitor the progression of the disease and assess the overall survival of the participants. The treatment period for brigimadlin is up to 21 days, while doxorubicin can be administered for a longer period, up to 126 days.

Throughout the study, participants will undergo regular assessments to track their response to the treatment. These assessments will include monitoring for any side effects and evaluating the quality of life through specific questionnaires. The study will also collect blood samples to analyze the drug's effects on the body and any changes in the tumor. The ultimate goal is to find a more effective treatment option for patients with this challenging type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient provides a signed and dated informed consent form. This is a document that confirms understanding and agreement to participate in the trial.

    Eligibility is confirmed based on specific criteria, including age, medical condition, and willingness to use birth control if applicable.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two treatment groups: one receiving brigimadlin (BI 907828) and the other receiving doxorubicin.

  3. Step 3

    Treatment administration

    For patients receiving brigimadlin (BI 907828), the medication is administered orally in the form of film-coated tablets. The specific dosage and frequency are determined by the study protocol.

    For patients receiving doxorubicin, the medication is administered through an intravenous infusion. The concentration is 2 mg/ml, and the dosage is determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment are monitored. This includes regular assessments of tumor size and progression using imaging techniques.

    Blood samples are collected for analysis of drug levels and tumor mutations.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is progression-free survival, which is the time during which the patient's cancer does not worsen.

    Secondary outcomes include objective response, overall survival, disease control, and health-related quality of life.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by May 27, 2026. At this point, final analyses of the data will be conducted to determine the effectiveness of the treatments.

Who can join the trial?

10 criteria

  • You must provide a signed and dated written consent form before any trial-specific procedures, tests, or analyses are done.
  • You must be a male or female who is at least 18 years old.
  • If you are a woman who can have children or a man who can father a child, you must use two reliable birth control methods starting from the screening, during the trial, and until 6 months and 12 days after the last dose.
  • You must have a confirmed diagnosis of **advanced dedifferentiated liposarcoma (DDLPS)** that cannot be removed by surgery and is getting worse or has come back.
  • A written report confirming the diagnosis of DDLPS with positive **MDM2** test results must be available.
  • Tumor samples must be available for review.
  • You must have at least one measurable tumor according to specific guidelines. If you have only one tumor, imaging must be done at least 2 weeks after any biopsy of that tumor.
  • You must have an **ECOG performance status** of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
  • You must be willing to donate blood samples for analysis related to the study.
  • Additional criteria may apply.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than advanced dedifferentiated liposarcoma cannot participate. This is a specific type of cancer that affects soft tissues.
  • Patients who have already received treatment for their cancer with drugs similar to doxorubicin cannot join. Doxorubicin is a medication used to treat cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for patients within certain age groups.
  • Patients who are not able to give their own consent to participate in the study cannot join. This means they must be able to understand the study and agree to be part of it.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This is to ensure the safety of the participants and the accuracy of the study results.
  • Patients who are pregnant or breastfeeding cannot join the study. This is to protect the health of the mother and the baby.
  • Patients who are currently participating in another clinical trial cannot join. This is to avoid any interference between different study treatments.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Brigimadlin (BI 907828)

    is an investigational medication being studied to see if it is more effective than the current standard treatment for patients with advanced dedifferentiated liposarcoma, a type of cancer. This medication is being tested to determine if it can help slow down or stop the growth of cancer cells in patients who have not received any prior treatment for their condition.

  • Doxorubicin

    is a well-established chemotherapy drug used as a standard treatment for various types of cancer, including advanced dedifferentiated liposarcoma. It works by interfering with the growth and spread of cancer cells in the body. In this trial, doxorubicin is being used as a comparison to evaluate the effectiveness of brigimadlin.

What is already known about the treatment

  • Brigimadlin

    Brigimadlin is administered orally and is currently being studied in clinical trials as a potential treatment for advanced dedifferentiated liposarcoma. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for brigimadlin is as a first-line treatment for this type of cancer. At the molecular level, brigimadlin works by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational anti-cancer agent.

  • Doxorubicin

    Doxorubicin is administered intravenously and is a well-established medication in the treatment of various cancers, including advanced dedifferentiated liposarcoma. It is widely recognized in medical literature and is commonly used as a first-line treatment for this condition. Doxorubicin works by intercalating DNA strands, thereby inhibiting the replication of cancer cells. It is classified as an anthracycline antibiotic and is known for its effectiveness in slowing or stopping the growth of cancer cells.

Investigated diseases

Advanced Dedifferentiated Liposarcoma – This is a type of cancer that originates in fat cells and is characterized by the presence of both well-differentiated and dedifferentiated components. It typically occurs in the deep soft tissues of the body, such as the retroperitoneum, which is the area behind the abdominal cavity. The dedifferentiated component is more aggressive and can grow rapidly, leading to a more challenging disease course. As the disease progresses, it may spread to other parts of the body, making it more difficult to manage. Symptoms can include a noticeable lump or swelling, pain, and discomfort in the affected area. The progression of the disease can vary, with some cases remaining localized while others may metastasize.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511361-11-00Protocol code1403-0008Estimated enrolment399 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.