Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of niraparib for ovarian cancer with a change to the BRCA gene that responded to platinum chemotherapy (NOVA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called niraparib for ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It is for women whose cancer has a change to the BRCA 1 gene or the BRCA 2 gene.
More about this trial
Ovarian cancer often responds well to chemotherapy that includes a
Niraparib is a type of biological therapy called a PARP inhibitor. This means it blocks an
The cells in your cancer already have problems repairing cell damage, because of the BRCA gene fault. Doctors hope that if they can also stop PARP working, the cancer cells will not be able to repair themselves and will die.
The women taking part in this trial have had chemotherapy at least twice and their cancer responded well each time. The aim of the study is to see if taking niraparib helps women in this situation, and whether it delays the cancer coming back again.
Who can enter
You may be able to join this trial if all of the following apply
- You have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that is
- You have a change to a gene called
BRCA1or BRCA2(if your doctor does not know whether you have a change to either of these genes, you will have a test to check this as part of the trial screening process)
- You have had at least 2 treatments of chemotherapy and both included a
platinum drug(your doctor can tell you more about this)
- Your last treatment was chemotherapy that included a platinum drug
- Your scans showed that your cancer had either gone away (
complete response) or had shrunk ( partial response)
- You have blood test results that show that you have a normal level of a
markercalled CA-125 (your doctor can tell you this)
- You finished your most recent chemotherapy in the past 8 weeks
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are able to swallow capsules
- You are willing to use at least 2 reliable forms of contraception during treatment and for 3 months afterwards if there is any chance you could become pregnant
- You are at least 18 years old
To be able to take part in this trial, the researchers need a sample of your primary cancer that was taken when you had surgery or a
You cannot join this trial if any of these apply. You
- Have cancer that has spread to your brain and is causing symptoms. You may be able to take part if the cancer spread has been treated, you have no further symptoms and are either taking a stable dose of steroids or no steroids
- Have cancer that is pressing on your spine (spinal cord compression) unless this was successfully treated and has not got any worse for at least 4 weeks
- Have had radiotherapy to control symptoms to more than a fifth of your bone marrow in the past week (your doctor can tell you this)
- Have a build up of fluid in your abdomen (
ascites) that you had drained during your last 2 treatments of chemotherapy
- Have had major surgery in the past 3 weeks or have not recovered from major surgery
- Still have any moderate or severe side effects from previous anti cancer treatment
- Have certain heart problems (the trial team can advise you about this)
- Have had another cancer in the past 2 years apart from non melanoma skin cancer that has been successfully treated
- Have a problem with your immune system (if you have only had your
spleenremoved you can take part)
- Have hepatitis B or hepatitis C
- Have any other medical condition that the trial team thinks could affect you taking part
- Are known to be sensitive to niraparib or any of its ingredients
- Have already had a drug similar to niraparib
- Are pregnant or breastfeeding
This is a phase 3 trial. The trial team need 360 women to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- 2 out of every 3 women will get niraparib
- 1 out of every 3 women will get a dummy drug (
Both niraparib and the dummy drug are capsules. You take 3 capsules once a day, if possible best in the morning. Your doctor may change your dose during treatment. You continue treatment as long as it is helping you and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire
- Before you start treatment
- Every 2 months for the 1st year of treatment
- Then every 3 months until you finish treatment
- 2 months after you finish treatment.
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for extra blood samples and a sample of your cancer that was removed when you had surgery or a
You see the doctor to have some tests before taking part. These tests include
During the 1st month of treatment you see the doctor once a week for a physical examination and blood tests. You have 2 heart traces done at the beginning of treatment and 4 weeks later. You then see the doctor every 4 weeks for a physical examination and blood tests. You have another CT scan or MRI scan at 8 weeks.
You see the doctor within a week of stopping treatment for a physical examination and blood tests. You then see the doctor every 3 months.
Niraparib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Loss of appetite
- Constipation or diarrhoea
- Shortness of breath
- A change to the way your heart works
- Difficulty getting to sleep
Your doctor will talk to you about the possible side effects before you agree to take part.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Jonathan Ledermann
NIHR Clinical Research Network: Cancer