"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at rucaparib for ovarian cancer that has come back (ARIEL2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at rucaparib (pronounced roo-kap-a-rib) for ovarian cancer, fallopian tube cancer and primary peritoneal cancer that has come back after chemotherapy. These cancers are all treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3.
Doctors can treat ovarian cancer with surgery and chemotherapy. Unfortunately sometimes the cancer can come back after treatment. The researchers want to find out if rucaparib may help in this situation.
Rucaparib is a type of drug known as a PARP inhibitor. PARP is an enzyme that helps damaged cells to repair themselves. If PARP is blocked, cancer cells may not be able to repair themselves.
The researchers will take tissue and blood samples to look for substances (biomarkers) such as
The aims of this trial are to
- Find a way of using the biomarkers to choose people with ovarian cancer who are most likely to respond to rucaparib
- Find out about the benefits of rucaparib for people with ovarian cancer
- Find out more about the side effects of rucaparib
- Find out more about how much rucaparib is in the body at different times
Who can enter
You may be able to enter this trial if
- You have epithelial ovarian cancer that is
high grade, fallopian tube cancer or primary peritoneal cancer
- Your epithelial ovarian cancer is serous or endometrioid type (your doctor can tell you this)
- Your last treatment was chemotherapy that included a
- Your cancer has got worse or came back but not for at least 6 months after your last platinum drug treatment
- You have had a scan that shows your cancer has got worse or come back
- You have at least 1 area of cancer from where a sample of tissue (
biopsy) can be taken and you are willing to have the biopsy taken within 4 weeks of starting treatment in the trial
- You are willing to provide a sample of cancer tissue that was removed when you had surgery or a previous biopsy
- You have at least 1 area of cancer that can be measured on a scan in addition to the area from where the biopsy will be taken
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you could become pregnant
- You are at least 18 years old
As well as all the above, you must have had a test to check for a change in the gene called BRCA if
- You were under 55 years old when you were diagnosed or
- You have had breast cancer or
- You have a close relative, such as your mother, sister, grandmother, aunt, or niece who has had ovarian cancer or breast cancer below the age of 50
You cannot enter this trial if
- Your cancer has spread to your spinal cord or brain unless you have no symptoms and have been stable for the past month
- You have had any cancer treatment, apart from hormone therapy, in the past 2 weeks
- You still have any major side effects from previous treatment
- You have had minor surgery in the past 5 days or major surgery in the past 3 weeks
- You have had another drug similar to rucaparib, apart from iniparib
- You have another cancer unless it was successfully treated and there is no sign of it and you finished chemotherapy more than 6 months ago or for a bone marrow transplant more than 2 years ago
- You have a problem with your
digestive systemthat affects how you absorb tablets
- You have taken any medication that has a strong effect on body proteins called cytochrome P enzymes in the past week
- You have HIV, hepatitis B or hepatitis C
- You have any other condition that could affect you taking part in this trial
- You are pregnant or breastfeeding
This is a phase 2 trial. It will recruit 180 people. Everyone taking part will have rucaparib.
Rucaparib is a tablet. Your doctor will tell you how many you need to take. You take them twice a day with a glass of water. You have a diary to record when you take your tablets and how many.
On certain days you take your tablets at the hospital and not at home. Your doctor will tell you when these days are.
There are certain foods and medicines that you can’t have when taking rucaparib. Your doctor will tell you about this.
You can continue with treatment as long as it is helping you and the side effects aren’t too bad.
If you agree to take part in this study, the researchers will ask for a new sample of your cancer (
You see the doctor to have some tests before taking part in this study. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Urine test
- CT scan
During treatment you see the doctor once a week for the first 2 weeks, at week 4 and then every 4 weeks. You have a CT scan every 8 weeks.
At the end of treatment you see the doctor for the same tests you had at the start. You then see the doctor again a month later to see how you are.
Rucaparib is a new drug and there may be side effects we don’t know about yet. The most commonly reported side effects include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Diarrhoea or constipation
- Tummy pain
- Loss of appetite and changes to taste
- A change to the way your liver works
Your doctor will talk to you about the possible side effects before you agree to take part in the study.
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.
Clovis Oncology Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer