Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study, called BURAN, is testing a new treatment approach for squamous cell carcinoma of the head and neck. This is a type of cancer that has either returned after previous treatment or has spread to other parts of the body. The study is comparing two groups of people: one group will receive a new drug called Buparlisib along with a common chemotherapy drug called Paclitaxel, and the other group will receive just Paclitaxel. The main goal is to find out if adding Buparlisib helps people live longer. Researchers will also look at how effective the treatment is at shrinking the cancer and how safe it is overall. It's a large-scale study, aiming to confirm earlier promising results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Adlai Nortye USA Inc.

Enrolment target

202

Start

24 Sep 2024

Recurrent or metastatic head and neck squamous cell carcinoma

What is this study about?

This research is focused on a type of cancer known as head and neck squamous cell carcinoma. This specific study is for patients whose cancer has either returned after being treated before (we call this 'recurrent') or has spread to other parts of the body (this is called 'metastatic'). These situations can be challenging to treat, and doctors are always looking for new and better ways to help patients.

The study is called BURAN and is a Phase III trial. This means it's a large and important stage of research, usually involving many patients, and aims to confirm if a new treatment is truly effective and safe compared to existing options. In this study, doctors are comparing two treatment plans. One plan involves giving patients a standard chemotherapy drug called Paclitaxel. The other plan involves giving patients Paclitaxel along with a new drug called Buparlisib.

The main question the researchers want to answer is whether adding Buparlisib to Paclitaxel helps patients live longer than receiving Paclitaxel alone. They will also be carefully watching to see how much the cancer shrinks or stops growing, how long these effects last, and if there are any side effects. This research aims to improve treatments available for this specific type of head and neck cancer.

Key takeaways

Tests a new combination treatment for advanced head and neck cancer.
Compares Buparlisib + Paclitaxel against Paclitaxel alone.
Main goal is to see if combination therapy helps patients live longer.
It's a large, important study (Phase III) to confirm earlier findings.
The study assesses both how well the treatment works and its safety.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older, with head and neck squamous cell carcinoma that has come back or spread. The study is open to both men and women.

There will be other detailed medical checks to ensure the study is right and safe for you. These might include checking your general health, previous treatments, and specific test results related to your cancer and overall body function.

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 head and neck squamous cell carcinoma?
Has your cancer come back or spread?
Are you able to take oral medication (capsules/tablets)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to one of two groups: either receiving Buparlisib combined with Paclitaxel, or receiving Paclitaxel alone. The drugs will be given in different forms; Paclitaxel is given as a liquid through a drip, while Buparlisib is taken as tablets or capsules. The dose of Buparlisib might be 50mg, 40mg, or 10mg, as decided by the study doctors.

Throughout the study, you would have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also ask you how you are feeling and if you are experiencing any side effects. The total length of your participation would depend on how your treatment is going and what the study protocol outlines, but generally, studies like this involve regular follow-up for some time even after treatment stops.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from a new treatment that could be more effective than current options, though there's no guarantee. Your health will also be closely monitored by a dedicated medical team. However, there may be side effects from the study drugs, some of which could be serious or unexpected. These will be explained in detail 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 (7)

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

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Unverified
Germany
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Unverified
Italy
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Unverified
Hungary
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Unverified
Spain
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Unverified
Belgium
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Unverified
Poland
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Unverified
France

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat cells of the head and neck area, like the mouth, throat, or voice box.

What does 'recurrent or metastatic' mean?

Recurrent means the cancer has come back after being treated before. Metastatic means the cancer has spread to other parts of your body.

What is the new drug, Buparlisib, supposed to do?

Buparlisib is designed to target specific pathways in cancer cells to stop them from growing and spreading. Researchers are hoping it will boost the effects of Paclitaxel.

Will I know if I'm getting the new drug?

No, this type of study is usually 'blinded', meaning you won't know which treatment group you are in. This helps ensure the results are as fair and accurate as possible.

How long will the treatment last?

Treatment duration varies for each person and depends on how you respond to the medication and any side effects. Your study doctor will explain this in more detail.