Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase I/II open label study to assess safety and preliminary evidence of a therapeutic effect of Azeliragon combined with conventional concurrent radiation and temozolomide in patients with newly diagnosed glioblastoma.

This research is testing a new drug called Azeliragon for newly diagnosed glioblastoma, a serious type of brain tumour. It's a two-part study (Phase I and Phase II) that combines looking at the drug's safety with seeing if it has a helpful effect. Patients taking part will receive Azeliragon along with the usual treatments for glioblastoma, which include radiation therapy and another medicine called temozolomide. The main goal is to find out if Azeliragon is safe to use with these standard treatments and to get an early idea of whether it could improve outcomes for patients. This is an 'open label' study, meaning both patients and their doctors will know they are receiving the new drug.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Cantex Pharmaceuticals Inc.

Enrolment target

Start

14 May 2024

Glioblastoma

What is this study about?

This research is a clinical trial focusing on a type of brain tumour called glioblastoma, which has been newly diagnosed. The study is investigating a new medicine named Azeliragon. The main purpose of this early-stage study is to see if Azeliragon is safe when given together with the standard treatments for glioblastoma. These standard treatments typically include radiation therapy and a medication called temozolomide.

The study is split into two parts: Phase I and Phase II. In Phase I, the focus is mostly on safety and finding the right dose of Azeliragon. In Phase II, once a safe dose is established, the study will look more closely at whether the medicine has any positive effects on the glioblastoma, while continuing to monitor safety. Researchers want to understand if adding Azeliragon to current treatments could be a better way to help patients.

By running this trial, doctors hope to gather important information about this new drug. If Azeliragon proves to be safe and shows signs of being effective in these early stages, it could eventually lead to new treatment options for people living with glioblastoma. This is a crucial step in developing new medicines.

Key takeaways

This study is testing a new drug called Azeliragon for glioblastoma.
It's an early-stage study focusing on safety and initial effectiveness.
Patients will receive Azeliragon alongside standard glioblastoma treatments.
The study is for adults (18+) newly diagnosed with glioblastoma.
Participation involves regular hospital visits for monitoring.

Who may be eligible?

This study is looking for volunteers who have recently been diagnosed with glioblastoma, a type of brain tumour. You must be an adult to take part, meaning you need to be 18 years old or older. There is no upper age limit, so older adults are also welcome to participate.

Both men and women are eligible to join this study. As it's an early-stage study, there are likely other specific health requirements or conditions that you would need to meet to ensure your safety and that the study results are clear. For example, you would typically need to be in a generally stable health condition apart from your glioblastoma, and your doctors would need to confirm that participating is suitable for you.

Your doctor would carefully review your medical history and current health to determine if this study is a good fit. They would check if your type of glioblastoma meets the study criteria and if any other health conditions you have would make it unsafe for you to take the new medicine or undergo the study procedures.

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 recently been diagnosed with glioblastoma?
Are you able to receive standard glioblastoma treatments (radiation and temozolomide)?
Are you generally in good health, aside from your glioblastoma?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening period to make sure you meet all the requirements. This would involve medical checks, tests, and discussions with the study team. If you are eligible, you would start receiving the study drug, Azeliragon, alongside your regular radiation therapy and temozolomide.

You would need to attend regular appointments at the hospital or clinic. These visits would involve check-ups, blood tests, and scans to monitor your health, how you're reacting to the treatments, and the progress of your glioblastoma. The study team would also ask you about any side effects you might be experiencing.

We don't have the exact duration of the treatment or follow-up from this summary, but clinical trials for glioblastoma can involve several months of active treatment followed by a period of regular monitoring. You would be fully informed about the schedule and all required visits before you make any decision to participate.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new medicine that may or may not improve your condition, and contributing to medical knowledge that could help future patients. However, there are also potential risks, including side effects from the new drug, which are not yet fully known, or from the combination of treatments. New treatments may not work as expected and could even cause unexpected problems. You will always 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.

—
Unverified
Spain

Common questions

What is glioblastoma?

Glioblastoma is an aggressive type of brain tumour that grows and spreads quickly. It's a serious condition that requires intensive treatment.

What is Azeliragon?

Azeliragon is a new experimental medicine being tested in this study. Its exact role in treating glioblastoma is what the researchers are trying to understand.

What does 'open label' mean?

Open label means that both you (as the patient) and your doctors will know that you are receiving the experimental drug, Azeliragon, as part of the study.

Will I still get my usual treatment?

Yes, if you participate in this study, you will receive Azeliragon in addition to the standard treatments for glioblastoma, which usually include radiation and temozolomide.

Why are they doing this study?

Researchers are doing this study to find out if Azeliragon is safe and if it can help improve outcomes for people with newly diagnosed glioblastoma when added to existing treatments.