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AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase 2a exploratory study of TAR-0520 gel in prevention of Hand and Foot Syndrome

This research is looking at a new gel, called TAR-0520, to see if it can help stop a skin problem known as Hand and Foot Syndrome (HFS). HFS can sometimes happen when people take certain cancer medications, like Capecitabine, causing redness, swelling, and soreness on the palms of the hands and soles of the feet. This study is in an early stage, called Phase 2a, meaning researchers are primarily focused on checking how safe the gel is and if it causes any unwanted side effects when used. They will also start to get an idea of whether the gel is effective in preventing or reducing the severity of this uncomfortable condition. The ultimate goal is to find better ways to help patients manage side effects of their cancer treatment.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Tarian Pharma
Enrolment target
25
Start
16 Feb 2026

What is this study about?

This study is investigating a new treatment called TAR-0520 gel. It's designed to help patients who are taking a cancer medicine called Capecitabine. A common side effect for some people on Capecitabine is Hand and Foot Syndrome (HFS). This can make your hands and feet red, swollen, and sometimes painful or blistered, making everyday activities difficult.

The main aim of this study is to see how safe the TAR-0520 gel is. Researchers will be carefully watching for any side effects people might experience while using the gel. They will also be looking to see if the gel helps prevent or reduce the seriousness of Hand and Foot Syndrome. This is an early-stage study, so it's about exploring whether the new gel works and is safe enough to be tested in more people.

Finding ways to manage side effects like Hand and Foot Syndrome is very important because it can significantly impact a person's quality of life during cancer treatment. If this gel proves to be safe and helpful, it could offer a new option to make cancer treatment more manageable for patients in the future.

Key takeaways

  • This study tests a new gel (TAR-0520) for Hand and Foot Syndrome.
  • It aims to make cancer treatment more comfortable by reducing side effects.
  • Researchers are looking at the gel's safety and how well it works.
  • Participation involves using the gel and regular check-ups.
  • You can stop participating at any time.
  • It's an early-stage study to gather initial information.

Who may be eligible?

To join this study, people need to be adults, aged 18 or older. There is no upper age limit, so older adults are welcome to participate as long as they meet other study requirements.

Both men and women can take part in this research. The study needs a diverse group of participants to understand how the gel works across different individuals.

Typically, participants would be people who are about to start taking or are currently taking the cancer medicine Capecitabine and are at risk of developing or have early signs of Hand and Foot Syndrome. Specific medical criteria will also need to be met, which the study team will discuss in detail.

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. Are you taking or about to start the cancer medicine Capecitabine?
  3. Are you willing to apply a gel to your hands and feet as instructed?
  4. Are you able to attend regular clinic appointments for check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be asked to use the TAR-0520 gel as instructed. The study team would explain exactly how and when to apply it. You would have regular visits to the clinic so the doctors and nurses can check on your health and how you are responding to the gel. This would involve physical examinations and discussions about any side effects you might be having.

During these visits, the study team would carefully record any changes in your hands and feet related to Hand and Foot Syndrome, and generally monitor your well-being. The total duration of your participation in the study would depend on the study plan, but typical early-stage studies can last for several weeks to a few months, including follow-up appointments after you stop using the gel. All assessments would be explained clearly beforehand.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new treatment (TAR-0520 gel) that could help prevent or reduce the severity of Hand and Foot Syndrome, a common and uncomfortable side effect of some cancer medications. However, there's no guarantee the gel will work for you. Potential risks might include side effects from the gel itself, such as skin irritation, although the study is designed to closely monitor for these. 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.
  • Unverified
    France

Common questions

What is Hand and Foot Syndrome?

It's a side effect of some cancer drugs that causes redness, swelling, soreness, and sometimes blistering on the palms of your hands and soles of your feet.

What is TAR-0520 gel?

It's a new gel being tested to see if it can help prevent or reduce the symptoms of Hand and Foot Syndrome.

Why is this study important?

It aims to find new ways to help patients manage uncomfortable side effects of their cancer treatment, improving their quality of life.

Will I definitely get the active gel if I join?

In some studies, participants might receive the active treatment or a placebo (dummy treatment). The study team will explain exactly what to expect.

How long will I have to be in the study?

The duration can vary, but early-stage studies often involve several weeks to a few months of participation, including follow-up visits. The study team will give you a clear timeline.

How to find out more

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

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