AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Artesunate, sulfasalazine polyunsaturated fatty acids, and iron in patients with solid tumors.

This study is investigating a new approach for treating solid cancers. Researchers are testing a combination of several substances: artesunate, sulfasalazine, polyunsaturated fatty acids (like those found in fish oil), and iron. This is an early-stage study, often called a Phase I trial. In this phase, the main goal is to understand how these different treatments are absorbed, distributed, processed, and removed by the body, as well as to check for their safety and identify appropriate doses. This helps scientists learn more about how these substances interact and whether they could be a helpful way to fight cancer in the future. It's open to adults aged 18 and over, both men and women, who have a solid tumour.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Hospital De Sant Pau I Santa Tecla

Enrolment target

Start

30 Jan 2025

Cancer

What is this study about?

This research study is focused on people who have solid cancers. Solid cancers are those that form a lump or mass, like breast cancer or lung cancer, as opposed to blood cancers like leukaemia.

The study is exploring a combination of different treatments. These include artesunate, which is often used for malaria but is also being looked at for its anti-cancer properties, and sulfasalazine, a drug used for inflammatory conditions like arthritis. Also included are polyunsaturated fatty acids, which are healthy fats found in foods like oily fish, and iron. Researchers want to see how these substances, when given together, affect cancer within the body.

This is an early-stage study, sometimes called a Phase I or 'Human Pharmacology' trial. This means it's one of the first times these specific combinations are being tested in people. The main aim at this stage isn't to cure cancer, but to understand how the body handles these treatments. This includes how much of the drugs get into your system, how long they stay there, and if they cause any side effects. This crucial information helps doctors decide on the safest and most effective doses for future, larger studies.

Key takeaways

This study is testing a new combination of treatments for solid cancers.
It's an early-stage (Phase I) study focused on safety and understanding how the treatments work.
The treatments include artesunate, sulfasalazine, healthy fats, and iron.
It's open to adults aged 18 and over, both men and women.
Participation involves regular visits, medication, and close medical monitoring.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, so people of all adult ages can potentially take part.

Both men and women are welcome to participate in this research. The study is specifically for individuals who have been diagnosed with a solid tumour, which means a type of cancer that forms a mass rather than affecting the blood or bone marrow.

When you talk to the study team, they will ask you some questions and may do some tests to make sure the study therapies are suitable and safe for you. This is also to ensure the results of the study are clear and reliable.

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 a diagnosis of a solid tumour (a cancer that forms a lump)?
Are you able to attend appointments at the study clinic?
Are you comfortable with taking new medications as part of a study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would likely have a series of visits to the study clinic. These visits would involve regular check-ups with doctors and nurses, blood tests to monitor your health and how the treatment is working, and possibly other scans or tests related to your cancer.

You would be given the study treatments – artesunate, sulfasalazine, polyunsaturated fatty acids, and iron – as directed by the study team. You would need to take these medications exactly as instructed. You'd also have follow-up appointments after your treatment period to see how you are doing in the longer term. The total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Potential benefits of taking part in this study are that you would receive close medical care and contribute to scientific knowledge that could help future patients. While there's no guarantee the treatment will directly benefit you, it might offer a new option. However, there are potential risks, as with any new treatment. You might experience side effects from the medications. The research team will discuss all known and potential risks with you in detail. Remember, 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.

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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for people who have solid tumours, which are cancers that form a lump or mass.

What does 'Phase I' mean?

Phase I means it's an early study to check if the treatment combination is safe and to find the right dose, rather than primarily looking for a cure.

Will I get better if I join this study?

There's no guarantee you will get better. The main aim of this early study is to learn more about the treatments, not necessarily to cure your cancer.

What are polyunsaturated fatty acids?

These are healthy fats, like the omega-3s found in fish oil, that are part of the study treatment.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.