A trial looking at ceralasertib for ovarian and endometrial clear cell cancers (ATARI)

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):

• ovarian cancer clear cell
• endometrial cancer clear cell 
• endometriosis related clear cell
• ovarian endometrioid
• endometrial endometrioid
• cervical cancer adenocarcinoma or squamous cell
• ovarian carcinosarcoma
• endometrial carcinosarcoma

And all of the following apply. You:

• have available a sample of tissue (biopsy ) from when you were diagnosed at first or when your cancer came back that the trial team can ask for. If this isn’t available, you are willing to give a new sample.
• have had a scan that shows your cancer has got worse since your last treatment and before you join the trial
• have had at least 1 treatment with a platinum drug  such as carboplatin
• have an area of cancer that can be seen and measured on a scan
• are fully active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• can swallow tablets or capsules
• are willing to use reliable contraception during treatment and for a month after if there is any chance you could get pregnant
• are at least 18 years old 

For groups 4 and 5 

The following must also apply. You:

• have had an immunotherapy such as a PD-1, PD-L1 or CTLA-4 inhibitor for at least 6 weeks. Your doctor will know this.
• have no ongoing side effects. If you had certain side effects from the treatment you might not be able to join the trial. Your doctor will know which side effects these are.
• weigh more than 30kg (4st 7lb)

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• had ceralasertib or another ATR inhibitor treatment. This depends on the type of cancer you have. Your doctor will know about this. 
• had a PARP inhibitor such as olaparib. This depends on the type of cancer you have. Your doctor will know about this.
• had chemotherapy within 3 weeks of starting the trial treatment
• had a targeted drug  within a month of starting the trial treatment
• had an immunotherapy  within 6 weeks of starting trial treatment
• had bevacizumab within a month of starting trial treatment
• had radiotherapy to relieve symptoms (palliative radiotherapy) within 3 weeks of starting trial treatment. For radiotherapy that included 30% or more of the bone marrow it is 4 weeks. If the treatment area was wide it is 4 weeks. Your doctor will know about this. 
• have another cancer or had a cancer that needed treatment in the past 3 years apart from cervical intraepithelial neoplasia  and non melanoma skin cancer
• have ongoing side effects from previous treatment apart from hair loss (alopecia)
• have pressure on your spine (spinal cord compression ) unless it has been treated and it has been stable for 4 weeks
• have cancer spread to the brain or spinal cord unless it has been treated, isn’t getting worse and have not had steroids for at least 4 weeks before joining the trial 
• have a myelodysplastic syndrome  (MDS) or acute myeloid leukaemia  (AML) or symptoms of these conditions 

For groups 4 and 5

You cannot join if any of the following also apply. You:

• are having any other treatment such as chemotherapy, a targeted drug or hormone treatment. This is apart from having hormone treatment for another reason other than cancer such as hormone replacement therapy (HRT).
• have very low levels of blood cells for more than 4 weeks that was due to previous treatment. You doctor will know this.
• have another cancer. This is apart from successfully treated non melanoma skin cancer , a type of melanoma skin cancer called lentigo maligna or a carcinoma in situ . You could join if you had a cancer more than 5 years ago that was treated with the aim to cure and there has not been any sign of it since. 

Medical conditions 
You cannot join this trial if any of these apply. You:

• have had an experimental drug as part of a clinical trial in the 4 weeks before joining the trial
• are taking medications such as certain antibiotics or herbal products such as St John’s Wort that affect the CYP enzymes. You might be able to take part if you can stop taking them. Your doctor can tell you about this.
• have a blockage in your bowel or you have symptoms of a bowel blockage within 6 weeks of joining the trial
• have blood in your urine and your doctor think this could affect you taking part
• have heart problems or have had in the past 6 months. This includes irregular heartbeats, chest pain (angina) that isn’t stable, a heart attack or heart failure.
• low blood pressure when you lie or sit down and your doctor think it could affect you taking part
• have an inherited  syndrome called ataxia telangiectasia
• have had major surgery within 4 weeks of joining the trial,  for minor surgery within 2 weeks before joining the trial
• have had a bone transplant with bone marrow from another person (allogeneic transplant ) or a double umbilical cord blood transfusion
• have taken corticosteroids at a dose of more than 10mg of prednisolone a day within 4 weeks of joining the trial
• have had blood cell growth factors  such as G-CSF or a blood transfusion within 2 weeks of joining the trial. You have had a red blood cell growth factor called erythropoietin  within 4 weeks of starting trial treatment or you might need it during treatment.
• have HIV, hepatitis B or hepatitis C
• have a problem with your liver , kidneys or lungs that your doctor think could affect you taking part
• have an active problem with bleeding
• have ongoing problem with feeling sick (nausea) or being sick (vomiting) or with your digestive system  that could affect how well medication is absorbed
• have an active infection caused by bacteria, fungus or virus that needs treatment that affects your whole body
• have fits (seizures) that isn’t controlled by medication
• have any other medical condition or mental health problem that the doctor or trial team think could affect you taking part

For groups 4 and 5 

You cannot join this trial if any of these also apply. You:

• have had an organ transplant and you are taking medication that damps down the immune system
• have or had an autoimmune disease or an inflammatory disease within the past 3 years. This is apart from certain ones that your doctor will know about.
• have or had problems that affect how well your immune system works
• are taking or have taken medication that damps down the immune system. This is apart from nasal sprays, creams, inhalers, local injections or a small dose of steroids. 

Other
You cannot join this trial if any of these apply. You:

• are allergic to any of the drugs or their ingredients used in this trial
• are pregnant or breastfeeding