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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to determine how nanatinostat is absorbed, modified, and removed from the body and the amount of nanatinostat that becomes available to the body in patients with cancers that is very large or has spread to other parts of the body

This early-stage study is investigating a new medication called nanatinostat for individuals living with advanced cancer, meaning their cancer is large or has spread in the body. The main goal is to understand how nanatinostat works in the human body. Researchers want to find out how it's absorbed, changed, and eventually removed. They also need to know how much of the drug actually becomes available to the body. This information is crucial for figuring out the safest and most effective dose to use in future, larger studies. It’s a very early step in hopefully developing new cancer treatments.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Viracta Therapeutics Inc., Viracta Therapeutics Inc.
Enrolment target
20
Start
12 Feb 2024

What is this study about?

Imagine your body as a complex machine. When you take a new medicine, this machine processes it. This study is like trying to understand exactly how your body processes a new medicine called nanatinostat. Specifically, for people with advanced cancer (cancer that's quite large or has spread), researchers want to learn several things: how the medicine gets into your system, what changes it undergoes once inside, and how your body eventually gets rid of it.

They also want to measure how much of the medicine actually reaches your bloodstream and is available to work. This isn't just curiosity; it's a really important step. By understanding how the body handles nanatinostat, doctors can figure out the best amount, or 'dose,' of the drug to give patients.

This is a very early stage of research, often called a 'Phase I' study. It's about gathering fundamental information on how the drug behaves in humans, not yet about seeing how well it treats cancer. The answers from this study will help guide future research and development of nanatinostat, hopefully leading to new treatment options down the line.

Key takeaways

  • This is an early study of a new drug called nanatinostat for advanced cancer.
  • The main goal is to understand how the body processes and uses the drug.
  • It helps researchers find the right dose for future studies.
  • Participation involves regular visits and medical tests.
  • Open to adults aged 18 and over with advanced cancer.
  • You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also participate.

This study is open to both men and women.

Crucially, you would need to have advanced cancer. This means your cancer is large, or it has spread to other parts of your body.

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. Am I 18 years old or older?
  2. Do I have a diagnosis of advanced cancer (large or spread cancer)?
  3. Am I willing to attend regular hospital or clinic visits?
  4. Am I able to take the study medication as instructed?
  5. Am I comfortable with having blood tests and other medical assessments?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to the clinic or hospital. During these visits, doctors and nurses will closely monitor how your body reacts to the new medication, nanatinostat. This will include taking blood samples at specific times to measure the drug levels in your body. You might also have other tests or assessments, such as physical examinations, to make sure you are tolerating the drug well. The exact number of visits, tests, and the total length of your participation would be fully explained to you before you decide to join.

Potential risks and benefits

While this is an early study primarily focused on understanding the drug's behaviour, potential benefits could include contributing to medical knowledge that might eventually lead to new treatments for advanced cancer. You might also receive close medical attention and monitoring. However, as with any new medication, there are potential risks and side effects, and these would be fully discussed with you by the research team. You are always free 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 kind of cancer is this study for?

This study is for people with advanced cancer, meaning cancer that is large or has spread to other parts of the body.

What is nanatinostat?

Nanatinostat is a new medicine being studied. This research aims to understand how it works in the body.

Will this drug treat my cancer?

This early study is mainly about understanding how the drug behaves in the body, not yet about treating cancer. It's a first step towards future treatments.

Who can take part in this study?

Adults aged 18 and over, both men and women, with advanced cancer may be eligible.

What will I have to do as part of the study?

You will have regular visits, take the study drug, and have tests like blood samples to see how your body handles the medicine.

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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