All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine

This study is for adults with solid tumours who have already taken part in a previous study using a medicine called brigimadlin. The main purpose is to see how well people can cope with taking brigimadlin for a longer period. Brigimadlin is a type of medicine being developed to treat cancer. Participants will take brigimadlin tablets every three weeks at the study site. Doctors will regularly check their health, look for any unwanted effects, and sometimes check the tumour size or if it has spread. You can stay in the study as long as the treatment helps you and you feel well enough to continue.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Boehringer Ingelheim
Enrolment target
90
Start
30 Dec 2024
Estimated completion
30 Dec 2030

What is this study about?

This study is designed for people who have solid tumours and have already started taking a medicine called brigimadlin in a previous research study. Solid tumours are growths of abnormal cells that can occur in many parts of the body. Brigimadlin is an investigational medicine, meaning it's still being studied, and it works by targeting certain cells involved in cancer growth. The goal of this new study is to understand more about how people tolerate brigimadlin when taken for a longer time.

Taking part would mean you continue to receive brigimadlin, similar to how you did in the first study. The research team will carefully monitor your health throughout. This careful monitoring helps them understand if the medicine continues to be helpful and if there are any side effects that develop over a longer course of treatment.

Research like this is very important because it helps doctors learn more about new medicines. By studying brigimadlin over a longer period, researchers can gather more information about its safety and how it affects solid tumours long-term. This information can then help more people in the future.

Key takeaways

  • This study is for people with solid tumours who have used brigimadlin before.
  • It aims to see how taking brigimadlin long-term affects people.
  • You will take tablets every three weeks at the study clinic.
  • Your health will be closely monitored, and side effects will be tracked.
  • You can continue treatment as long as it's beneficial and you tolerate it well.

Who may be eligible?

This study is specifically for adults who have solid tumours and are already receiving brigimadlin as part of another research study sponsored by the same company. You need to be well enough to continue working with the study team and follow the study instructions.

Before joining, you'll need to sign a consent form, which means you understand what the study involves and agree to take part. Women who could become pregnant and men who could father a child must agree to use effective birth control throughout the study and for a period afterwards.

You would not be able to join if your doctor believes that taking brigimadlin would not be safe for you, or if you are pregnant, breastfeeding, or planning to become pregnant. Also, if you need to take other medicines that might interfere with brigimadlin or the study, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult with solid tumours?
  2. Are you currently taking brigimadlin in another research study?
  3. Are you able to follow the study schedule and visit the clinic regularly?
  4. If you could become pregnant or father a child, are you willing to use effective birth control?
  5. Does your doctor think brigimadlin is safe for you to continue?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will continue to take brigimadlin tablets once every three weeks. You will need to visit the study site for each dose. During these visits, the doctors and nurses will check your overall health, ask how you are feeling, and look for any unwanted effects the medicine might be causing. They will perform tests, which might include blood tests, and sometimes check the size of your tumour or whether it has spread.

There isn't a fixed end date for your participation; you will stay in the study for as long as the treatment appears to be helping you and you are able to tolerate it well. If the treatment isn't working for you or if the side effects are too much, you can stop participating. You will have regular appointments to ensure everything is going smoothly.

Potential risks and benefits

The main potential benefit of joining this study is that you would continue to receive brigimadlin treatment, which was previously helping you or was well-tolerated. This could mean continued management of your solid tumour. As with any medicine, there are potential risks, and brigimadlin can cause side effects. The study team will carefully monitor you for any unwanted effects. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Precision NextGen Oncology
    Verified postcode
    Beverly Hills, United States
  • Sarcoma Oncology Center
    Verified postcode
    Santa Monica, United States
  • Yale Cancer Center
    Verified postcode
    New Haven, United States
  • Mayo Clinic Cancer Center
    Verified postcode
    Jacksonville, United States
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States
  • Nebraska Cancer Specialists-Omaha-69066
    Verified postcode
    Omaha, United States
  • Northwell Health
    Verified postcode
    Lake Success, United States
  • West Cancer Center & Research Institute
    Verified postcode
    Germantown, United States
  • Henry-Joyce Cancer Clinic
    Verified postcode
    Nashville, United States
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Utah Cancer Specialists Cancer Center
    Verified postcode
    Salt Lake City, United States
  • Fred Hutchinson Cancer Research Center
    Verified postcode
    Seattle, United States

Common questions

What kind of tumours is this study for?

This study is for people with 'solid tumours', which are abnormal growths of cells found in many parts of the body, as opposed to blood cancers.

What is brigimadlin?

Brigimadlin is a research medicine being tested to treat cancer. It's designed to target specific pathways involved in cancer growth.

How often do I take the medicine?

You will take brigimadlin as tablets once every three weeks at the study site.

How long will I be in the study?

You can stay in the study for as long as the treatment is helping you and you are feeling well enough to continue.

Do I have to pay to be in the study?

No, you will not have to pay for the study medicine or study-related visits and tests.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.