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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ERibulin in Advanced Solitary fibrous tumor, an ItaliaN sarcoma Group phase II study (ERASING)

This clinical trial, called ERASING, is looking into a medicine named Halaven for people with advanced solitary fibrous tumour. This is a type of cancer that affects soft tissues. Doctors want to see if Halaven can shrink the tumours and stop them from growing for a longer time. They will also be checking if it helps people live longer and if it improves their general well-being. The study will measure how many people respond to the treatment and how safe it is. If you're over 18 and have this condition, you might be able to take part. It's an important step to find better treatments for this specific cancer.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Italian Sarcoma Group
Enrolment target
20
Start
01 Oct 2024

What is this study about?

This study is called ERASING, which stands for "ERibulin in Advanced Solitary fibrous tumor, an ItaliaN sarcoma Group phase II study". It’s all about finding new and better ways to treat a specific type of cancer called solitary fibrous tumour, especially when it’s considered 'advanced'. In advanced cancer, it means the disease may have spread or is harder to treat with standard options.

The main goal of this study is to see how well a medicine called Halaven (its scientific name is Eribulin) works. Researchers are particularly interested in seeing if this medicine can make tumours shrink. They will carefully measure the tumours to see if they get smaller or stop growing. This is a crucial step in understanding if Halaven could be a helpful treatment for people with this condition.

Beyond just shrinking tumours, the doctors will be looking at other important things too. For example, they want to know if taking Halaven can help people live longer, and if it can slow down the cancer from growing or spreading (this is called progression-free survival). They will also check if people taking the medicine feel better overall and how safe the medicine is, meaning they'll look for any side effects.

Key takeaways

  • This study is testing a new medicine called Halaven for advanced solitary fibrous tumour.
  • It aims to see if Halaven can shrink tumours and slow disease progression.
  • Anyone 18 years or older with this specific cancer may be eligible.
  • Participation involves regular clinic visits for medication and health checks.
  • The study will also look at how safe Halaven is and any side effects.

Who may be eligible?

To be able to join this study, you would need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.

Both men and women can take part in this research. The study isn't limited by gender, so anyone aged 18 or over, regardless of whether they are male or female, could be eligible.

Beyond age and sex, the most important criteria is that you have been diagnosed with advanced solitary fibrous tumour. Your doctors will check other specific medical details to make sure the study is right for you and safe for you to join.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced solitary fibrous tumour?
  3. Are you able to attend regular hospital or clinic appointments?
  4. Are you willing to receive the study medicine, Halaven, by injection?
  5. Are you prepared to have regular health checks and scans?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the medicine called Halaven. This is given as an injection. You would need to attend regular appointments at the hospital or clinic so the study team can give you the medication and check your health. They will do various tests, like scans, to see how your tumour is responding to the medicine and if there are any changes.

You would also have regular check-ups with the doctors and nurses to monitor how you are feeling and to look out for any side effects from the medicine. The study team will explain how often these visits will be and what each visit will involve. They will also let you know how long they expect you to be taking the medicine and participating in the study.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study could be access to a new treatment, Halaven, which might help to shrink your tumour or slow its growth. However, there's no guarantee it will work for everyone, and it might not help you personally. Like all medicines, Halaven can have side effects, which the study team will explain in detail. You will be closely monitored for these side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

Common questions

What is solitary fibrous tumour?

It's a rare type of cancer that usually starts in the soft tissues of the body, but can appear in other places too.

What is Halaven?

Halaven is a medicine being tested in this study to see if it can treat advanced solitary fibrous tumour.

What does 'Phase II' mean?

Phase II means the study is looking more closely at how well the medicine works and its safety, after initial testing.

Will I get the active drug or a dummy pill?

In this study, everyone who takes part will receive the Halaven medicine. There is no placebo or dummy treatment.

How long will the study last for me?

The study team will discuss the expected duration of your participation, which depends on how your body responds to the treatment.

How to find out more

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

Discussion

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