
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is for people with certain subtypes of gynaecological cancers that have come back after treatment. It is open to people with ovarian or endometrial clear cell cancers and certain types of other rare gynaecological cancers particularly endometrioid, carcinosarcoma or cervical cancers.
Cancer Research UK supports this trial.
Ceralasertib is a called an ATR inhibitor. In healthy cells ATR proteins help repair damage to
before the cells divide. From laboratory research we know it can kill cancer cells that have a change (
) in the ARID1A
.
Certain rare types of ovarian, endometrial and other gynaecological cancers particularly clear cell types often have this change in the ARID1A gene. Researchers think that ceralasertib might work for people with these types of cancer.
Research in the laboratory also showed having an ATR inhibitor with another targeted drug called a PARP inhibitor might also kill cancer cells without the change in the ARID1A gene.
Olaparib is a PARP inhibitor. It works by stopping the protein PARP from working. The protein PARP helps damaged cells repair themselves. Doctors already use olaparib to treat ovarian cancer and some other types of cancer.
In this trial some people have ceralasertib on its own and some people have ceralasertib with olaparib.
The aims of this trial are to find out:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if you have one of the following cancers that has continued to get worse or came back after treatment (recurred):
And all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 2 trial.
You agree to the trial team asking for a piece of cancer tissue from when you were first diagnosed or from when your cancer came back. If this isn’t available you must agree to give a new tissue sample.
This is to confirm what type of cancer you have. For people with endometrial clear cell cancer, ovarian clear cell cancer or endometriosis-related clear cell cancer it is also to look for certain changes (mutations and protein loss) related to the ARID1A gene.
There are 2 stages in this trial. The 2nd stage will open to recruitment if the results of the 1st stage look promising.
In the 1st stage there are 4 groups (cohorts). At the start 10 people join each group. The team will ask more people to join if the treatment looks promising.
Group 1A
This group is for people with clear cell cancer of the ovaries, endometrium or endometriosis related and your cancer cells have the abnormal ARIDA1 protein.
In this group you have ceralasertib on its own.
Group 1B
This group is for people with clear cell cancer of the ovaries, endometrium or endometriosis related and your cancer cells have the abnormal ARIDA1 protein.
In this group you have ceralasertib in combination with olaparib.
The researchers will only open this group if ceralasertib isn’t working for people in group 1A.
Group 2
This group is for people with clear cell cancer of the ovaries, endometrium or endometriosis related and your cancer cells don’t have the abnormal ARIDA1 protein.
In this group you have ceralasertib in combination with olaparib.
Group 3
This group is for people with:
Your cancer cells may or may not have the abnormal ARIDA1 protein.
In this group you have ceralasertib and olaparib.
Treatment
Ceralasertib is a tablet. You take it at the same time each day. You swallow the tablets whole with a glass of water on an empty stomach. This means you can’t eat any food for 2 hours before taking them and within 1 hour after.
For group 1
People in group 1 take 2 tablets twice day for 2 weeks. You then have 2 weeks of not taking the tablets. Each 4 week period is a .
For groups 2 and 3
People in group 2 and 3 take 2 tablets of ceralasertib a day once a day for a week. You then have 3 weeks of not taking the tablets. This 4 week period is a cycle of treatment.
Olaparib is a tablet. You take 2 tablets twice a day every day. This should be at the same time each day. You swallow them whole with a glass of water. When you take olaparib with ceralasertib you have it on an empty stomach. When you take olaparib on its own you don’t have to take it on an empty stomach.
In each group you continue to have treatment as long as it is working and the side effects aren’t too bad.
Medicines and food to avoid
There are certain medications, herbal products and foods you shouldn’t have when taking ceralasertib. These include:
You shouldn’t eat:
Your doctor will tell more about this.
Research samples
You give extra blood samples during the trial. The team take these when you have your routine bloods taken.
You see the doctor to have tests before taking part. These tests include:
You see the doctor at the start of treatment and then during treatment at:
This is for blood tests and to see how you are.
You have a CT scan and or an MRI scan every 8 weeks.
You see the doctor at the end of treatment and a month later for blood tests and to see how you are. And then every:
You have a scan every 8 weeks for the first year and then every 12 weeks.
During treatment if your cancer gets worse you stop treatment and are followed up every 3 months.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
ceralasertib is a new drug and there might be side effects we don’t know about yet. The side effects we do know about is a drop in blood cells that might cause an increased risk of:
Ceralasertib might also make your skin more sensitive to sunlight. So it is best not to go out in the sunlight too often while having ceralasertib.
An allergic reaction can happen with all drugs and this can be life threatening. Contact your doctor or the health advice line if you have any of the following that might signs of an allergic reaction:
We have information on olaparib.
Your doctor or a member of the trial team will talk to you about the possible side effects of ceralasertib and olaparib before you agree to join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Susana Banerjee
AstraZeneca
Cancer Research UK
Institute of Cancer Research (ICR)
Lady Garden Foundation
This is Cancer Research UK trial number is CRUKE/18/014.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.