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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

NXP800 in subjects with Ovarian Cancer

This is a very early study investigating a new drug called NXP800. It's designed for women who have ovarian, fallopian tube, or primary peritoneal cancer that has unfortunately become resistant to standard platinum-based chemotherapy. Researchers are particularly interested if your cancer has a specific genetic change called an ARID1a mutation. Because this is the first time NXP800 is being used in humans, the main aim is to understand how safe it is, how the body handles it, and what side effects it might have. Scientists also want to see if there are any early signs that it could help treat this specific type of cancer. This study is an important step in developing new treatment options.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Nuvectis Pharma Inc.
Enrolment target
8
Start
25 Mar 2024

What is this study about?

This study is about a new potential medicine called NXP800. It's being tested in women who have ovarian cancer, or cancers of the fallopian tube or the lining of the abdomen (primary peritoneal cancer). These specific types of cancer are being studied because they have not responded to a common chemotherapy treatment called platinum-based therapy, and they also have a particular genetic change called an ARID1a mutation.

Think of this study as a very first step. Because NXP800 has never been given to people before, the main goal is to check its safety. Doctors will be carefully watching to see if there are any side effects and how the body processes the medication. They will also be looking for initial signs that the drug might be effective in treating the cancer.

Finding new treatments is a long process, and studies like this are crucial. If NXP800 proves to be safe and shows early promise, it could move on to larger studies in the future, bringing us closer to more options for difficult-to-treat cancers.

Key takeaways

  • This is an early-stage study (Phase 1) of a new drug, NXP800.
  • It's for women with certain ovarian, fallopian tube, or peritoneal cancers.
  • The cancer must be resistant to platinum chemotherapy and have an ARID1a gene change.
  • The main aim is to check the drug's safety and how the body handles it.
  • Participants will receive the new drug and be closely monitored.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be a woman aged 18 or older.

You would be considered for this study if you have ovarian cancer, cancer of the fallopian tube, or cancer of the lining of the abdomen (primary peritoneal cancer). It's important that your cancer has previously been treated with platinum-based chemotherapy but unfortunately has not responded, or has come back after this treatment. Furthermore, your cancer must have a specific genetic change that doctors call an ARID1a mutation.

Quick self-check
  • Am I a woman?
  • Am I 18 years old or older?
  • Do I have ovarian cancer, fallopian tube cancer, or primary peritoneal cancer?
  • Has my cancer not responded to or come back after platinum-based chemotherapy?
  • Does my cancer have an ARID1a genetic change?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study drug, NXP800. This is an early-stage study, so visits and assessments would be frequent and thorough. You would have regular check-ups, blood tests, and other scans or procedures as needed to monitor your health, how the drug affects you, and whether it's having any impact on your cancer. The exact number of visits and the duration of your involvement would be explained in detail by the study team, but typically, early-stage studies involve intensive monitoring. After receiving the treatment, there would also be a follow-up period to continue monitoring your health.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might not directly benefit from this study, as its main purpose is to understand the drug's safety and how the body handles it. However, you would be helping medical science advance and potentially discover new treatments for others in the future. Potential risks could include side effects from the study drug, which are currently unknown as it's new to humans, or side effects from procedures like blood tests. The study team will explain all known and potential risks to you. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Spain

Common questions

What is NXP800?

NXP800 is a new medicine being tested for the first time in people to see if it's safe and how it works in the body.

What does 'platinum-resistant' mean?

It means your cancer has not responded well to, or has grown despite, chemotherapy treatments that contain platinum.

What is an 'ARID1a mutation'?

This is a specific change in the genes of your cancer cells that doctors look for. Not all cancers have it.

Will this study cure my cancer?

This is a very early study, so it's not known if NXP800 will cure cancer. The main goal is to check its safety and early effects.

Can men join this study?

No, this particular study is only open to women because it's focused on cancers that affect female reproductive organs.

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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