Study on Long-Term Safety of BI 907828 for Patients with Solid Tumors Who Previously Participated in a Study with This Medicine

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called brigimadlin in patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study involves patients who have already participated in a previous trial with brigimadlin. Brigimadlin is taken as a film-coated tablet and is designed to be used as a monotherapy, meaning it is used alone without combining it with other treatments.

The purpose of this study is to evaluate how safe and tolerable brigimadlin is over a long period. Participants will continue taking brigimadlin and will be monitored for any side effects that may occur during the treatment. The study will look at how often these side effects happen, how severe they are, and how they relate to the treatment. This information will help understand the long-term effects of using brigimadlin in treating solid tumors.

Participants in this study will take brigimadlin orally, which means they will swallow the tablets. The study will last for a maximum of 60 days, during which the participants will have regular check-ups to monitor their health and any side effects they might experience. The study aims to ensure that brigimadlin is safe for long-term use in patients with solid tumors who have already been treated with this medication in a previous trial.

1 beginning of trial participation

Upon joining the trial, ensure that you have provided a signed and dated, written informed consent form. This is necessary before any trial-specific procedures, sampling, or analyses can begin.

Confirm that you meet all the inclusion criteria, such as ongoing treatment with brigimadlin or eligibility for crossover treatment from a previous trial.

2 treatment administration

You will receive brigimadlin in the form of a film-coated tablet. This medication is taken orally.

The dosage, frequency, and duration of administration will be determined based on the protocol of the trial you are participating in.

3 monitoring and assessments

Throughout the trial, you will be monitored for any treatment-emergent adverse events. These are side effects that may occur during the treatment period.

Regular visits and laboratory tests will be scheduled to assess your health and the effects of the treatment.

4 use of birth control

If you are a woman of childbearing potential or a man able to father a child, you must use two medically acceptable methods of birth control. This is required from the start of the trial until a specified period after the last dose of the medication.

5 completion of trial participation

The trial is estimated to end on December 31, 2036. Your participation will continue until the trial concludes or until you meet the criteria for discontinuation.

Who Can Join the Study?

  • The patient is currently receiving or is eligible to switch to brigimadlin treatment in a related study.
  • The patient has signed and dated a written consent form, agreeing to participate in the study.
  • Women who can have children and men who can father a child must use two reliable methods of birth control, starting from the screening phase, during the study, and for a specified period after the last dose of the study drug.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and adhere to lifestyle and study guidelines.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • Any side effects from previous cancer treatments must have improved to a mild level, except for hair loss and menstrual issues, which can be any level, and nerve damage, which must be mild or moderate.
  • For certain patients, they must be eligible to continue treatment as per the guidelines of the study they are currently in. If they are experiencing a delay due to side effects, they can still participate if they recover within the allowed time.
  • For other patients, they must be eligible to switch to this study directly from their current study, without receiving any other cancer treatments unless allowed by their current study.

Who Cannot Join the Study?

  • Patients who have not previously participated in another trial in the brigimadlin program cannot join this study.
  • Patients with medical conditions other than solid tumors are not eligible. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas.
  • Patients who are part of a vulnerable population are not allowed to participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Clinico San Carlos Madrid Spain
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Quironsalud Barcelona Barcelona Spain
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Karolinska University Hospital Solna Sweden
Clinexpert Kft. Budapest Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cvafwmsqg Uqoqtiazirvyzb Sdsuqkfch Woluwe-Saint-Lambert Belgium
Cetzle Lzpp Bjccrz Lyon France
Iiaozuaa Czzjlc Dcsknrnajgitphmtt L'hospitalet De Llobregat Spain
Nuynnkam Iixbwvey Onlhhjmfe Imz Mdnhq Sfoeuyzfvgewtximzzjqclbqlpro Inltonfo Bsbegxkh Cracow Poland
Umwjshpfvg Om Asyqghx Edegem Belgium
Hkknthlf Vxxq drqgztvl Barcelona Spain

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
09.12.2024
Czechia Czechia
Recruiting
09.12.2024
Denmark Denmark
Not recruiting
09.12.2024
France France
Not recruiting
09.12.2024
Germany Germany
Recruiting
09.12.2024
Hungary Hungary
Recruiting
09.12.2024
Italy Italy
Recruiting
09.12.2024
Norway Norway
Not recruiting
09.12.2024
Poland Poland
Recruiting
09.12.2024
Spain Spain
Recruiting
09.12.2024
Sweden Sweden
Not recruiting
09.12.2024

Trial locations

Brigimadlin is a medication being studied for its long-term safety in patients with solid tumors. It is taken orally, which means it is swallowed in the form of a pill. The main goal of this trial is to see how safe brigimadlin is when used over a long period. Researchers are looking at any side effects that might happen while taking this medication, how often they occur, how serious they are, and whether they are related to the medication. This study is for patients who have already been part of another trial involving brigimadlin, and it aims to gather more information about its safety and tolerability.

Investigated diseases:

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, solid tumors can invade nearby tissues and organs, potentially disrupting their normal function. The growth rate and behavior of solid tumors can vary widely depending on their type and location. Over time, they may spread to other parts of the body through the bloodstream or lymphatic system.

Trial ID:
2024-514177-21-00
Protocol code:
1403-0032
Trial Phase:
Therapeutic exploratory (Phase II)

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