Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

This study is looking at a new medicine called berubicin, given through a drip, for adults who have a serious type of brain tumour called glioblastoma (GBM). This is for people whose cancer has returned after they've had the usual first treatments. We'll be comparing berubicin with a standard treatment called Cecenu® to see how well it works and if it's safe. The main goal is to find out if berubicin helps people live longer. We'll also check how long it takes for the cancer to grow or return, how many people see their tumour shrink or stay stable, and any side effects people might experience. This is a Phase II study, which means it's an earlier stage of testing a new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cns Pharmaceuticals Inc.

Enrolment target

126

Start

26 Sep 2024

Glioblastoma multiforme (GBM)

What is this study about?

This study is for adults who have a type of brain tumour called glioblastoma, which is a very serious and aggressive cancer. Unfortunately, for many people, glioblastoma can come back even after initial treatments. When that happens, doctors are always looking for new and better ways to help.

This study is testing a new medicine called berubicin. We want to see how well it works compared to a standard treatment, Cecenu®, and if it's safe to use. You'll either receive berubicin given through an IV drip, or Cecenu®, which comes as capsules. The main thing we'll be looking at is whether berubicin helps people live longer. We'll also be tracking other important things like how long it takes for the cancer to start growing again, if the tumours shrink or stay the same size, and what any side effects are.

Finding new treatments for glioblastoma is really important because it's such a challenging cancer. Studies like this help us understand if new medicines can offer hope to patients when their cancer returns. Your participation could help us learn more and potentially help future patients with this condition.

Key takeaways

This study is for adults with glioblastoma that has come back.
It tests a new IV medicine called berubicin against a standard treatment, Cecenu®.
The main aim is to see if berubicin helps people live longer.
Both treatment's safety and how well they work will be monitored.
Participation involves regular clinic visits, scans, and blood tests.
You can leave the study at any time if you change your mind.

Who may be eligible?

This study is specifically for adults, aged 18 years and older, who have been diagnosed with glioblastoma. It's important that your glioblastoma has come back after you've already had the usual first treatments for this type of cancer.

Both men and women can take part in this study. The doctors and nurses running the study will carefully check your medical history and current health to make sure that taking part is safe for you and that you meet all the necessary 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?
Have you been diagnosed with glioblastoma?
Has your glioblastoma returned after your first treatments?
Are you able to attend regular clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, the first step is called 'randomisation'. This means you will be randomly assigned to receive either the new medicine (berubicin) or a standard treatment (Cecenu®). It's like flipping a coin, so neither you nor your doctor can choose which treatment you get.

Throughout the study, you will have regular visits to the clinic. These visits will involve blood tests, physical examinations, and special scans, like MRI scans, to check the size of your tumour and how you are responding to the treatment. The doctors will also carefully monitor any side effects you might experience. Treatment will continue as long as it's safe for you and the cancer isn't getting worse. The study will track your health from the time you start treatment until the end of your life, even after you stop the study treatment, to collect information about how the treatments affect long-term survival.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available, which could be more effective than existing options. You will also receive very close medical attention and monitoring. However, there's no guarantee that the treatment will work for you, and you might experience side effects that can range from mild to severe. These side effects will be carefully monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What is glioblastoma?

Glioblastoma is a serious type of brain cancer that can grow quickly. It's quite challenging to treat, and unfortunately, it often comes back after initial treatments.

What is 'standard first line therapy'?

This refers to the usual initial treatments doctors recommend for glioblastoma, which often include surgery, radiation, and chemotherapy.

What does 'intravenously infused' mean?

It means the medicine, berubicin, is given directly into your bloodstream through a drip, usually in your arm.

What is a 'randomized control arm'?

It means some people in the study will get the new medicine, and others will get an existing treatment or a placebo (dummy treatment), chosen randomly, so we can compare them fairly.

What does Phase II mean?

Phase II means this is an earlier stage of testing a new treatment. It's looking to see if the medicine works and if it's safe for a larger group of people than in a Phase I study.