Study on the Safety and Tolerance of BI 907828 in 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 a rare form of cancer that develops in fat cells. The study is testing a new treatment called brigimadlin (BI 907828), which is taken as a film-coated tablet. The purpose of the study is to evaluate the safety of brigimadlin in patients with advanced or metastatic dedifferentiated liposarcoma by monitoring any side effects that may occur during treatment.

Participants in the study will receive brigimadlin and will be monitored over a period of time to assess how well they tolerate the treatment. The study will look at the occurrence of any side effects, how severe they are, and how they relate to the treatment. The study will also observe how the cancer responds to the treatment, including whether it shrinks or stops growing.

The study is designed to include patients who have either not received any prior treatment for their cancer or have already undergone some form of treatment. The treatment will be administered orally, and the study will continue for several months to gather comprehensive data on the safety and effectiveness of brigimadlin. The ultimate goal is to determine if brigimadlin can be a safe and effective treatment option for patients with this 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 study.

Eligibility is confirmed based on criteria such as age, medical condition, and previous treatments. The patient must have a diagnosis of dedifferentiated liposarcoma and meet other specific medical requirements.

2 treatment initiation

The patient begins treatment with brigimadlin (BI 907828), which is administered as a film-coated tablet taken orally.

The dosage and frequency of administration are determined by the study protocol and the patient’s specific medical condition.

3 monitoring and assessments

Throughout the study, the patient undergoes regular monitoring to assess the safety and effectiveness of the treatment.

This includes tracking any side effects, known as treatment-emergent adverse events (TEAEs), and evaluating their severity and frequency.

4 evaluation of treatment response

The patient’s response to the treatment is evaluated using criteria such as objective response, progression-free survival, and overall survival.

These assessments help determine the effectiveness of the treatment in controlling the disease.

5 completion of study participation

The study is estimated to conclude by December 31, 2025. The patient’s participation may end earlier if specific criteria are met, such as disease progression or withdrawal of consent.

Upon completion, the patient may receive follow-up care as determined by their healthcare provider.

Who Can Join the Study?

Provide a signed and dated written informed consent form. This means you agree to participate in the study after understanding all the details.
Be a male or female who is 18 years old or older at the time of signing the consent form.
If you are a woman who can have children or a man who can father a child, you must use two reliable methods of birth control. This should start from the screening phase, continue during the study, and last for a specific time after the last dose of the study medication.
Have a confirmed diagnosis of a type of cancer called dedifferentiated liposarcoma (DDLPS) that is advanced or has spread to other parts of the body. It should not be possible to remove it with surgery, or it should be getting worse or coming back. There are two groups in the study: one for those who have not had treatment for DDLPS before, and one for those who have had treatment.
Have a written pathology report confirming the diagnosis of DDLPS. This report should show positive results for a test called MDM2 immunohistochemistry or MDM2 amplification, which are specific tests done on the cancer cells.
Have at least one measurable tumor that can be tracked during the study. If there is only one tumor, the initial scan must be done at least two weeks after any biopsy of that tumor.
Have an ECOG performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
Have a life expectancy of at least 3 months from the start of treatment, as judged by the study doctor.
Meet additional criteria that apply to the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than dedifferentiated liposarcoma cannot participate. Dedifferentiated liposarcoma is a type of cancer that starts in fat cells.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are taking certain medications that might interfere with the study treatment cannot participate.
Patients who have had another cancer treatment recently that might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Akbabrh Ooufkjsohba Usrrizopxfwyr Cgqcrujqemnl Diyfj Spssfi E Dhdmv Spaxpjp Dm Tqrowc	Turin	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.03.2024
Italy	Not recruiting	12.03.2024

Trial locations

Investigated drugs:

(3S,3'S,3A's,10A's)-6-Chloro-3'-(3-Chloro-2-Fluorophenyl)-1'-(Cyclopropylmethyl)-6'-Methyl-2-Oxo-1,2,3',3A',10',10A'-Hexahydro-1'H-Spiro[Indole-3,2'-Pyrrolo[2',3':4,5]Pyrrolo[1,2-B]Indazole]-7'-Carboxylic Acid

Brigimadlin (BI 907828) is the main medication being studied in this clinical trial. It is being tested for its safety and effectiveness in patients with advanced dedifferentiated liposarcoma, a type of cancer. The trial aims to understand how often and how severe any side effects are when patients take this medication. The study will also look at how these side effects relate to the treatment and what happens as a result.

Investigated diseases:

Dedifferentiated liposarcoma

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 or limbs. The dedifferentiated component is more aggressive and can grow rapidly, leading to a mass that may cause discomfort or interfere with normal bodily functions. As the disease progresses, it can invade surrounding tissues and potentially spread to other parts of the body. The growth of the tumor can lead to symptoms such as pain or swelling, depending on its location.

Trial ID:

2023-504522-19-00

Protocol code:

1403-0019

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Tolerance of BI 907828 in Patients with Advanced Dedifferentiated Liposarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?