Active not recruitingPHASE3INTERVENTIONAL

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

This study is investigating a new medicine called Niraparib for women who have advanced ovarian cancer. After finishing their initial chemotherapy treatment, if their cancer has responded well (meaning it has shrunk or gone away), they will be offered either Niraparib or a dummy drug (placebo). The main aim is to find out if Niraparib can help keep the cancer from coming back or growing for longer. Researchers will follow participants for about seven years to gather all the necessary information. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Tesaro, Inc.

Enrolment target

733

Start

11 Jul 2016

Estimated completion

29 May 2026

Ovarian Neoplasms

Results

Results from this study

Posted June 2020

Results have been published for this study.

Primary outcome

Progression Free Survival

Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

Full results on the registry

What is this study about?

This research study is for women who have advanced ovarian cancer. Advanced means the cancer has spread beyond its original location (Stage III or IV). The study is looking into a drug called Niraparib. The purpose is to see if taking Niraparib after your first round of chemotherapy can help prevent the cancer from coming back or getting worse.

After you've had your initial chemotherapy treatment, and if your doctors find that your cancer has responded well (either shrinking or going into remission), you might be offered the chance to be part of this study. You would either receive Niraparib or a placebo, which looks like the drug but contains no active medicine. This allows researchers to compare the two groups fairly and see if Niraparib is truly effective.

This is important because for many women with advanced ovarian cancer, the cancer can return after initial treatment. Finding a way to keep the cancer from coming back for longer could be a big step forward in treatment. The study will carefully watch how participants respond over several years.

Key takeaways

Study for advanced ovarian, fallopian tube, or primary peritoneal cancer.
Tests Niraparib vs. placebo after first chemotherapy.
Aims to keep cancer from returning or growing for longer.
Participants monitored for about 7 years.
You might receive the drug or a dummy pill.
Close medical supervision throughout the study.

Who may be eligible?

This study is for women who have a specific type of ovarian, fallopian tube, or primary peritoneal cancer (high-grade serous or endometrioid) that is advanced (Stage III or IV).

You must have completed your first course of platinum-based chemotherapy, and your cancer must have responded well to it, meaning it has shrunk significantly or can no longer be seen. This includes if you had chemotherapy before surgery, or if you had surgery first and then chemotherapy. Your blood tests (like CA-125) also need to show that your cancer is under good control after chemotherapy. You'll need to join the study within 12 weeks of your last chemotherapy dose.

However, you can't join if you have certain other types of ovarian cancer (like mucinous or clear cell), or if you had Stage III cancer that was completely removed by surgery and there's no visible cancer left.

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.

Do I have Stage III or IV high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer?
Has my cancer responded well (shrunk or gone) after my first platinum-based chemotherapy?
Did I complete between 6 and 9 cycles of platinum-based chemotherapy?
Is it within 12 weeks of my last chemotherapy treatment?
Do I *not* have mucinous or clear cell ovarian cancer subtypes?
If my Stage III cancer was completely removed by surgery, is there still visible disease?

Answer every question to see your result.

What does participation involve?

If you join this study, you would either receive the study drug, Niraparib, or a placebo (a dummy pill). You wouldn't know which one you are getting, and neither would your study doctor. You would take this medication regularly over a period of time. You'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This is called 'maintenance treatment' because it happens after your main cancer treatment.

The researchers will follow your health and the status of your cancer for approximately seven years. This long follow-up helps gather comprehensive information about the drug's effects over time. You'll also need a pregnancy test if you could become pregnant. All participants will have a special test on their tumour tissue to understand more about its features.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new treatment that might help keep your cancer under control for longer than standard care. However, like all medications, Niraparib can have side effects, and some may be serious. You would be closely monitored for any reactions. There is also no guarantee that the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (116)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Tempe, United States
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Tucson, United States
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Tucson, United States
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San Francisco, United States
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San Francisco, United States
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Santa Rosa, United States
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New Haven, United States
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Jacksonville, United States
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Miami, United States
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Atlanta, United States
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Savannah, United States
GSK Investigational Site
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Geneva, United States

Common questions

What is 'maintenance treatment'?

Maintenance treatment is when you receive a drug regularly after your main cancer treatment has worked, to try and stop the cancer from coming back or getting worse.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.

Can I choose whether I get Niraparib or the placebo?

No, in this type of study, participants are randomly assigned to either the drug or the placebo group, and neither you nor your doctor will know which one you're receiving.

How long will I be involved in the study?

The study itself will collect data for about seven years, meaning they will keep track of your health and cancer status for that time, even if you stop taking the study drug earlier.

What if my cancer starts to get worse during the study?

Your doctors will monitor you closely. If your cancer progresses, or if the treatment isn't working for you, you and your doctor will discuss your next steps, which may include stopping the study treatment.