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

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What is this study about?

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.

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 randomization

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Hm Sanchinarro Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Netherlands Cancer Institute Amsterdam The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital De Santa Maria E.P.E. Lisbon Portugal
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Bioclinic S.A. Thessaloniki Greece
Hippokration Hospital Athens Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Karolinska University Hospital Solna Sweden
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Universidade De Santiago De Compostela Santiago De Compostela Spain
Cliniche Gavazzeni S.p.A. Bergamo Italy
University Hospital Olomouc Olomouc Czechia
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cvybcx Lxrr Bgfgwi Lyon France
Ucmjwgelieuhhrtdicxyc Emyip Agz Essen Germany
Lrcqf Ukbjjgyjlatk Mifrzsl Cpwadbz (dzeaj Leiden The Netherlands
Idxlyzyd Cynevn Dghodhvdqtksorjub L'hospitalet De Llobregat Spain
Ftsnoqln nnlyrlvul Mzgqk a Hnieebj Prague Czechia
Awptlzwarj Psbovbjk Hrergvcz Dz Mjsadicql Marseille France
Htggeaol Ugqzlabtco Cyidorq Hgfvansf Helsinki Finland
Kbtmrsuv dqp Uvvpqurbkghr Mxesuyju Ags Munich Germany
Hzfhznur Db Lf Swyhm Cwww I Spng Pwh Barcelona Spain
Fnfzxytia Purl Le Izmunsbohlwoi Bgfsgxicy Dfv Hubnqylg Ushoevhzofemo Lx Peu Madrid Spain
Hbuymlyz Vgww ddrqzfkc Barcelona Spain
Cbbtsg Ovfuf Lmvntzo Lille France
Ujykgxkftx Gagamqw Hicauxdi Abfttdt Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.03.2022
Czechia Czechia
Not recruiting
31.03.2022
Finland Finland
Not recruiting
31.03.2022
France France
Not recruiting
31.03.2022
Germany Germany
Not recruiting
31.03.2022
Greece Greece
Not recruiting
31.03.2022
Italy Italy
Not recruiting
31.03.2022
Norway Norway
Not recruiting
31.03.2022
Portugal Portugal
Not recruiting
31.03.2022
Spain Spain
Not recruiting
31.03.2022
Sweden Sweden
Not recruiting
31.03.2022
The Netherlands The Netherlands
Not recruiting
31.03.2022

Trial locations

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.

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 ID:
2024-511361-11-00
Protocol code:
1403-0008
Trial Phase:
Therapeutic use (Phase IV)

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