Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study in people with advanced cancer to test whether the amount of BI 907828 in the blood is influenced by taking an OATP inhibitor or a CYP3 inhibitor

This research is for people with advanced solid cancer. It's a very early-stage study (Phase 1) focused on understanding how a new drug, BI 907828, works inside the body. The main goal is to find out if taking certain other common medicines (called OATP inhibitors or CYP3 inhibitors) at the same time changes the amount of BI 907828 in a person's blood. This helps doctors figure out the safest and most effective way to give the new drug in the future. It's not testing if the drug treats cancer yet, but rather how it moves through and is processed by the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

24 Sep 2024

Solid cancer tumors

What is this study about?

This study is about a new medicine called BI 907828 for people who have advanced forms of solid cancer. 'Solid cancer' means it forms a lump or tumour, like breast cancer, lung cancer, or bowel cancer, rather than cancers of the blood. 'Advanced cancer' means the cancer has spread from where it started to other parts of the body.

The main purpose of this particular study is to understand how the new medicine, BI 907828, acts inside your body. It's like trying to understand how a car engine works. Researchers want to see how much of the medicine gets into your bloodstream and how your body processes it. This helps them work out the best and safest dose.

A key part of this study is to see if other medicines you might be taking could change how BI 907828 works. Specifically, they are looking at medicines that are called 'OATP inhibitors' or 'CYP3 inhibitors'. Many common medicines fall into these groups, and they can sometimes affect how other drugs are absorbed or broken down by your body. By understanding this, doctors can make sure that when BI 907828 is given in the future, it's combined safely and effectively with other necessary treatments.

Key takeaways

This study is for adults with advanced solid cancer.
It helps researchers understand how a new drug, BI 907828, works in the body.
The study checks if other common medicines change amounts of BI 907828 in the blood.
It's a Phase 1 study, focused on safety and how the drug is processed, not on treating cancer yet.
Participation involves taking the new drug and having regular check-ups.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There is no upper age limit, so older adults can also take part. The study is open to everyone, regardless of whether they are male or female.

To be considered for this study, you must have an advanced solid cancer. This means your cancer has spread beyond the original site. The research team will check other health details to make sure this study is safe and appropriate for you.

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.

Are you 18 years old or older?
Have you been diagnosed with an advanced solid cancer?
Are you able to attend regular clinic visits?
Are you currently taking or willing to take specific other medications (OATP or CYP3 inhibitors) as part of the study?
Are you comfortable potentially taking a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the new investigational medicine, BI 907828. You will also, at certain times, take either an OATP inhibitor or a CYP3 inhibitor medicine, which are common types of drugs that can affect how other medications work. You will have regular visits to the clinic for check-ups, blood tests, and possibly other assessments like scans, to see how the medicine is affecting you and how your body is processing it. The exact number of visits, tests, and the total length of time you'd be in the study would be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is gaining a better understanding of how this new drug works, which could help future patients. You might also have closer monitoring of your health during the study. However, because BI 907828 is a new drug, there might be side effects that are not yet fully known. Also, taking other drugs alongside it could change how it affects your body. You will be told about all known risks before you decide to join. Remember, you can always choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Spain

Common questions

What does 'advanced cancer' mean in this study?

It means the cancer has spread from where it started to other parts of your body.

What is a Phase 1 study?

It's a very early-stage study that mainly focuses on how a new medicine works in the body and its safety, rather than if it treats the disease.

Will taking this drug cure my cancer?

This study is not designed to find out if the drug cures cancer, but to understand how it behaves in your body. It's a very early step in drug development.

What are OATP and CYP3 inhibitors?

These are types of common medicines that can affect how your body absorbs or breaks down other drugs. The study wants to see how they affect BI 907828.

Can I stop participating in the study at any time?

Yes, you have the right to leave the study at any point, and it won't affect your regular medical care.