Ongoing, recruitingTherapeutic use (Phase IV)Interventional

NIRAPK : Study of the relationships between pharmacokinetic properties (PK) and hematological toxicity of niraparib in ovarian cancer

This study, called NIRAPK, focuses on a treatment for ovarian cancer called niraparib (brand name Zejula). It's designed to understand why some people experience specific side effects, particularly those affecting their blood or kidneys, when taking this medication. Researchers will look at how the body processes the drug, alongside other health information, to find connections. By doing this, they hope to identify what might make someone more likely to develop these side effects. This is a Phase IV study, meaning it's looking at the drug's use in real-world settings after it's already been approved. The goal is to make treatment safer and more personalised for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospices Civils De Lyon

Enrolment target

Start

10 Jul 2024

Patients with high-grade serous epithelial ovarian tubal or primary peritoneal cancers

What is this study about?

This study, known as NIRAPK, is investigating a medication called niraparib, also known as Zejula. It's used to treat certain types of ovarian cancer, including those affecting the fallopian tubes or the lining of the abdomen. The main goal is to understand how the drug works in individual patients and why some people might experience specific side effects.

The researchers are particularly interested in two types of side effects: those affecting the blood (called hematological toxicity) and those affecting the kidneys (renal toxicology). They want to identify factors — such as a patient's overall health, other medicines they are taking, or even their diet — that might influence how the body handles niraparib and whether these side effects occur. By gathering this information, they hope to predict who might be more likely to develop these side effects.

Ultimately, this research aims to make treatments for ovarian cancer safer and more effective. By understanding these connections, doctors may be able to better manage side effects or tailor treatment plans to each individual, improving the overall experience and outcomes for patients.

Key takeaways

This study explores how niraparib (Zejula) affects ovarian cancer patients.
It aims to understand why some patients get blood or kidney-related side effects.
Researchers will collect details about your health, diet, and how your body handles the drug.
The goal is to improve treatment safety and personalisation for ovarian cancer.
Your quality of life will also be monitored throughout the study.

Who may be eligible?

This study is looking for women who have been diagnosed with certain types of ovarian cancer. Specifically, you would need to have high-grade serous epithelial ovarian cancer, or cancer of the fallopian tube, or primary peritoneal cancer.

You must be at least 18 years old to take part. There is no upper age limit, meaning women of any age above 18 can be considered.

All participants must be female. The study will focus on understanding how specific treatments affect women with these conditions.

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 female?
Are you 18 years old or older?
Have you been diagnosed with high-grade serous epithelial ovarian cancer?
Have you been diagnosed with fallopian tube cancer?
Have you been diagnosed with primary peritoneal cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be taking niraparib (Zejula) hard capsules as prescribed. The study will involve giving regular blood samples to understand how your body is processing the drug. Researchers will also collect information about your general health, other medications you're taking, and your diet. You will also be asked to answer questions about your quality of life, which helps to understand how the treatment is affecting your daily well-being. The exact number of visits, tests, and total duration will be discussed with you by the study team, as it depends on your individual treatment plan and how long you are on the medication.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as contributing to a better understanding of your medication, which might help future patients. For you, it means your treatment will be closely monitored, and any side effects will be carefully watched. However, there are potential risks, including the usual side effects associated with niraparib, and the inconvenience of extra clinic visits or blood tests. 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
France

Common questions

What is niraparib (Zejula)?

Niraparib (Zejula) is a medication used to treat certain types of ovarian cancer. It comes as a hard capsule.

What kind of side effects are they looking at?

The study is specifically looking at side effects that affect your blood (like low blood counts) and your kidneys.

Why is this study important?

This study aims to understand why some patients get side effects from niraparib, so doctors can better predict and manage them, making treatment safer and more effective for everyone.

Who can join this study?

Women aged 18 or older with specific types of ovarian, tubal, or primary peritoneal cancer can be considered.

Will my regular doctors still treat me?

Yes, you will continue to receive care from your regular medical team. The study involves additional monitoring related to your niraparib treatment.