A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
This study is for women with advanced ovarian cancer that has responded well to their first chemotherapy. It's looking at a new treatment, niraparib, to see if it can help prevent the cancer from coming back or getting worse for longer. Half the participants will receive niraparib, and the other half will get a dummy pill (placebo). No one, including the doctors, will know who is getting which until the study is over. Researchers want to measure how long patients stay healthy without their cancer progressing, and also look at overall survival and quality of life. The aim is to confirm if niraparib is a helpful treatment after initial chemotherapy.
At a glance
What is this study about?
This research study is about a new way to help women with a type of advanced ovarian cancer. After you've had your first main treatment (chemotherapy) and it has worked well, sometimes the cancer can still come back. This study is testing if a drug called niraparib can help stop the cancer from returning, or at least keep it away for longer. Think of it like a maintenance treatment – something you take regularly after the main treatment to keep the good effects going.
To make sure the results are fair and accurate, this study is set up in a special way. Some women will receive the actual drug, niraparib, while others will get a tablet that looks exactly the same but contains no medicine (this is called a placebo or dummy pill). Neither you nor your doctor will know which one you are taking. This helps scientists truly understand if the niraparib is making a difference, rather than other factors.
The main thing the doctors want to find out is whether niraparib helps people live longer without their cancer getting worse (they call this "progression-free survival"). They will also be looking at overall survival, which means how long people live generally. The study will also carefully check how the drug affects your quality of life, using special questionnaires to understand your daily well-being, pain levels, and how you feel emotionally. All this information helps us understand if niraparib is a good and safe option for women like you.
Key takeaways
- Tests a new drug (niraparib) for advanced ovarian cancer.
- Aims to prevent cancer from returning after chemotherapy.
- Compares niraparib to a dummy pill; no one knows who gets what.
- Will look at how long patients stay healthy and their quality of life.
- Only for women whose cancer responded well to first chemotherapy.
- Requires a specific genetic feature in the cancer.
Who may be eligible?
This study is looking for women who are 18 years old or older. You would need to have a specific type of advanced ovarian cancer, and your cancer must have responded well to your initial chemotherapy treatment.
Your medical team will need to confirm that your cancer has certain genetic features, specifically related to something called "homologous recombination deficiency." This is a technical term that means your cancer cells have particular characteristics that might make niraparib more effective for you.
There will be other detailed medical checks to make sure the study is right and safe for you. Your doctor will discuss all of these with you and explain if you meet the full requirements.
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 older?
- Do you have advanced ovarian cancer?
- Has your cancer responded well to your initial chemotherapy?
- Has your doctor confirmed your cancer has the specific 'homologous recombination deficiency' characteristic?
What does participation involve?
If you decide to take part, you would receive either the study drug, niraparib, or a matching dummy pill. You would take this medication regularly. You would have scheduled visits to the hospital or clinic for blood tests, physical examinations, and to answer questionnaires about your health and how you're feeling. These questionnaires help researchers understand your quality of life. The study will continue for a certain period, and you'll be monitored closely throughout to see how you're responding and to check for any side effects. The exact number and frequency of visits, as well as the total duration you'd be involved, would be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is niraparib?
Niraparib is an experimental drug being tested to see if it can help keep ovarian cancer from coming back after initial chemotherapy.
What is a 'dummy pill'?
A dummy pill (placebo) looks exactly like the study drug but contains no active medicine. It helps researchers compare the drug's effects accurately.
Will I know if I'm getting the drug or the dummy pill?
No, neither you nor your doctor will know which you are receiving during the study. This is called 'double-blind'.
What does 'advanced ovarian cancer' mean?
It means the cancer has grown and possibly spread beyond the original site in the ovary.
What does 'homologous recombination deficiency' mean?
It refers to a specific genetic feature in your cancer cells that might make them more likely to respond to this type of treatment. Your doctor can explain this in more detail.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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