RecruitingPHASE2INTERVENTIONAL

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

This research study is investigating new ways to prescribe niraparib, a medication used to treat ovarian cancer, to women who have recently been diagnosed with advanced stages of the disease (Stage III or IV high-grade ovarian cancer). The main goal is to see if starting with a lower dose and carefully increasing it, or using other dose adjustments, can help reduce unpleasant side effects like changes in blood counts. Researchers also want to find out if these changes in dosing lead to fewer interruptions or stopping of treatment, and how long women remain free from the cancer growing again. The study is for women who have already completed their main chemotherapy treatment and responded well to it.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

21 Aug 2023

Estimated completion

01 Sep 2027

Ovarian Cancer Stage III Ovarian Cancer Stage IV Ovarian Cancer High Grade Ovarian Serous Adenocarcinoma

What is this study about?

This research study is looking for better ways to give a medicine called niraparib to women who have advanced ovarian cancer. Specifically, it's for women with high-grade ovarian, primary peritoneal, or fallopian tube cancer that is Stage III or IV, who have recently finished their main chemotherapy treatment.

Niraparib is a type of treatment that helps stop cancer cells from growing. It's often given after chemotherapy to help keep the cancer from coming back. Sometimes, niraparib can cause side effects, and these might lead to patients needing to pause their treatment, lower their dose, or even stop taking the medicine altogether. This study wants to see if starting with a different dose, or adjusting it carefully over time, could lead to fewer such problems, making the treatment easier to manage for patients while still being effective. The main things the study wants to learn are how often side effects happen, if dose adjustments help, and how long people stay cancer-free.

Understanding if different ways of giving niraparib can help manage side effects and keep patients on their treatment for longer is very important. This could mean a better quality of life for women undergoing treatment for ovarian cancer and potentially lead to more successful long-term outcomes. The study will follow patients for two years to see how they are doing.

Key takeaways

Exploring new dosing strategies for niraparib in ovarian cancer.
Aims to reduce treatment side effects and interruptions.
For women with advanced ovarian cancer who completed chemotherapy.
Focuses on safety, tolerability, and how long cancer remains controlled.
Requires regular check-ups and monitoring over two years.

Who may be eligible?

To join this study, you need to be a woman aged 18 or older with newly diagnosed advanced ovarian cancer (Stage III or IV) that is high-grade. This also includes similar cancers of the fallopian tube or peritoneum.

You must have recently finished at least four cycles of platinum-based chemotherapy (like carboplatin or cisplatin) and responded well to it, meaning your cancer has significantly shrunk or is no longer detectable, and your CA-125 blood test results are good. Your general health should be satisfactory, reflected by an ECOG score of 0 or 1, and your blood tests for organ function should be within acceptable limits. You also need to be able to understand the study and agree to take part.

Women who are able to become pregnant must use reliable birth control during and for some time after the study. If you have gone through menopause or had a surgery that stops you from getting pregnant, that's fine too. The study drug must start within 12 weeks of finishing your chemotherapy.

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 a woman aged 18 or over?
Have you been diagnosed with advanced (Stage III or IV) high-grade ovarian, fallopian tube, or primary peritoneal cancer?
Have you recently completed at least 4 cycles of platinum-based chemotherapy with a good response?
Is your general health good, and are your blood tests within acceptable limits?
Are you able to agree to use reliable birth control if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be taking the study drug, niraparib. The study team will explain how and when to take it. You will have regular appointments at the study clinic for check-ups, blood tests, and to monitor any side effects you might experience. These visits will also help the doctors decide if your dose needs to be adjusted. The study aims to follow participants for up to 24 months (two years) to see how well the treatment works and how you are feeling. Throughout this period, there will be assessments to track your progress and overall health. The exact number of visits and tests will be detailed by the study team.

Potential risks and benefits

Like all treatments, niraparib can have potential benefits, such as helping to keep your cancer from returning or growing after chemotherapy. However, there are also potential risks, including side effects like changes in your blood count or other reactions. The study aims to find ways to reduce these side effects. You will be closely monitored by the study team, and they will explain all known risks before you decide to take part. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw at any time without it affecting your future medical care.

Locations (1)

Sunnybrook Research Institute
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is niraparib?

Niraparib is a tablet medicine used after chemotherapy for ovarian cancer to help prevent the cancer from coming back.

What kind of ovarian cancer is this study for?

This study is for women with newly diagnosed advanced (Stage III or IV) high-grade ovarian cancer, or similar cancers of the fallopian tube or peritoneum.

Why are they studying different doses?

Researchers want to see if adjusting the dose of niraparib can help reduce side effects, making the treatment easier to tolerate and allowing patients to stay on it for longer.

Do I have to have finished chemotherapy already?

Yes, you must have completed at least four cycles of platinum-based chemotherapy and responded well to it before starting this study.

How long will the study last for me?

The study plans to follow participants for about two years (24 months) to see the long-term effects of the treatment.

How to find out more

Dr. Allan Covens, MD

al.covens@sunnybrook.ca 416-480-4026 Official trial record

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