Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 0 lead-in trial of Pitavastatin in primary and recurrent Glioblastoma patients

This is a very early study looking at a medication called Pitavastatin for adults with a serious brain tumour called Glioblastoma. The study includes people who have been recently diagnosed as well as those whose cancer has returned. The main goal of this first phase of research is to understand how Pitavastatin behaves in the body, such as how it's absorbed and processed. It's a small-scale study, often called a 'Phase 0' or 'Phase I' trial, which means it's about gathering initial safety and dose information, rather than checking if the drug can cure the cancer. This kind of research is an important step in finding new ways to treat tough conditions like Glioblastoma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

16 Oct 2023

Glioblastoma Multiforme

What is this study about?

This study is a very early stage of research, sometimes called a 'Phase I' study, which looks at a drug called Pitavastatin. It's for adults who have a kind of brain tumour known as Glioblastoma. This includes people who have recently found out they have Glioblastoma, as well as those whose tumour has come back after treatment.

The main aim of this first step is to carefully check how Pitavastatin works in the human body. Researchers want to understand things like how much of the drug gets into the body, how it's used, and how it leaves the body. This helps them decide the best way to give the drug and understand if it might be safe to test further. It's not designed to see if the drug can cure Glioblastoma at this stage, but rather to gather important basic information.

Finding new and better treatments for serious conditions like Glioblastoma is very important. Studies like this, even at these early stages, are a crucial part of developing new medicines. They help scientists learn valuable things about how potential new drugs behave, which can then lead to bigger studies in the future if things look promising.

Key takeaways

This is an early research study on Pitavastatin for Glioblastoma.
It aims to understand how Pitavastatin acts in the body.
Open to adults aged 18 and over, both men and women.
Includes people with new or returning Glioblastoma.
Participation involves regular visits and health checks.
This trial is a first step in exploring potential new treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There isn't an upper age limit mentioned, meaning older adults can also be considered.

The study is open to both men and women.

Crucially, you would be someone with a diagnosis of Glioblastoma. This would include people who have just been diagnosed with this type of brain tumour, as well as those whose Glioblastoma has returned after previous treatments. More specific medical details about your health and your Glioblastoma would be checked by the study team to ensure you meet all the requirements.

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?
Do you have a diagnosis of Glioblastoma?
Has your doctor confirmed that you might be suitable for an early-phase trial?
Are you able to attend regular clinic visits for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a number of visits to the study clinic or hospital. These visits would involve regular health checks, perhaps some blood tests, and scans to see how your body is responding and how the drug is affecting you. You would be given the study drug, Pitavastatin, as instructed by the study team.

The total duration of your participation would depend on the study design, but for early-phase trials, it often involves an initial treatment period followed by regular check-ups or follow-up appointments. The study team would explain the exact schedule of visits, what will happen at each visit, and how long they expect you to be involved, so you have a very clear picture of the commitment required.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. For this early-stage trial, a potential benefit is contributing to medical knowledge that could help future patients with Glioblastoma. There's also a chance you might experience some effect from the study drug, though this trial isn't primarily designed to treat the cancer at this stage. Possible risks include side effects from Pitavastatin, some of which may be unknown as it's being tested in a new way. There's also the time commitment and the potential for discomfort from tests and procedures. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is Glioblastoma?

Glioblastoma is a serious and aggressive type of brain tumour.

What is Pitavastatin?

Pitavastatin is a medication, and in this study, researchers are looking at how it works in people with Glioblastoma.

What does 'early-stage study' mean?

It means this is one of the first times this drug is being tested in people with this condition, mainly to understand safety and how it behaves in the body.

Will this drug cure my cancer?

This early study isn't designed to find a cure; its main goal is to understand how the drug works and if it's safe enough for further research.

Can women take part?

Yes, this study is open to both men and women.

How to find out more

Official trial record

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