A study of ceralasertib for advanced cancer (Dose escalation study)

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join the study if you are in one of the following situations.

You have solid cancer  that has spread to another part of the body and there is no further standard treatment .

Or

You have non small cell cancer (NSCLC) and:

• Your cancer has spread into the surrounding tissue (locally advanced) or has spread to another part of the body
• Your cancer has come back after or continued to grow during your first course of chemotherapy treatment (first line treatment )
• There is no further standard treatment
• You have at least 1 area of cancer that measures 10mm or more across (15mm or more for a lymph node ) that can be seen on a scan and hasn’t been treated with radiotherapy

Or

You have a head and neck cancer that is a squamous cell cancer  and:

• Your cancer has spread into the surrounding tissue (locally advanced) or has spread to another part of the body
• Your cancer has come back after or continued to grow during your first course of chemotherapy treatment (first line treatment)
• Your chemotherapy included 5FU and a platinum drug such as carboplatin or cisplatin
• There is no further standard treatment
• You have at least 1 area of cancer that measures 10mm or more across (15mm or more for a lymph node) that can be seen on a scan and hasn’t been treated with radiotherapy

Or

You have:

• High grade epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer

And:

• Your cancer is sensitive to  platinum drugs . Your doctor will know this
• You have had a targeted drug called a PARP inhibitor
• Your cancer is getting worse when you join the study

Or

You have:

• High grade womb cancer that is either endometrial or serous type. That is getting worse when you join the study
• Had a PARP inhibitor

And all of the following apply, you:

• Have satisfactory blood test results
• Are fully active but can’t do heavy physical work (performance status 0 or 1) and this hasn’t got worse in the past 2 weeks
• Are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any chance you or your partner could become pregnant
• Are at least 18 years old

You cannot join this study if any of these apply.

Cancer related

• Your cancer is pressing against your spinal cord (spinal cord compression )
• Your cancer has spread to the brain unless you have no symptoms, it is stable and you have not been taking steroids for at least 4 weeks before starting treatment in this study
• You have had any anti cancer drug treatment in the past 4 weeks
• You have had radiotherapy within 4 weeks of starting treatment, 1 week if it was a small area to relieve symptoms apart from radiotherapy to more than 30% of the bone marrow
• You have ongoing side effects from previous treatment apart from hair loss
• You have had steroids within the 4 weeks before starting treatment
• You have had an experimental drug as part of a clinical trial within 4 weeks of starting treatment
• You have had another cancer apart from successfully treated cervical intra epithelial neoplasia (CIN ), ductal carcinoma in situ (DCIS ),  non melanoma skin cancer or early  endometrial cancer. You might be able to join if you have had a solid cancer or lymphoma that doesn't affect the bone marrow that was treated with the aim to cure  and there hasn't been any sign of it for more than 3 years. 

Medical conditions

• You have ataxia telangiectasia
• You have had a heart attack in the past 6 months or another heart problem such as heart failure, unstable angina or unstable heart rhythm
• You have high blood pressure that isn’t controlled by medication
• You have a problem with your digestive system  such as Crohn’s disease or IBS that could affect how ceralasertib is absorbed
• You have fits (seizures) that can’t be controlled  with medication
• You have an infection that needs to be treated with drugs such as antibiotics that reach your whole body (systemic treatment )
• You have HIV, hepatitis B or hepatitis C
• You have any other medical or mental health condition that the team think could affect you taking part in the study

Other

• You are taking any medication that affects the CYP enzymes or the Pgp protein
• You have had ceralasertib or any drug that works in the same way
• You are allergic to ceralasertib or any of its ingredients
• You have had olaparib, or a similar drug, before
• You are pregnant or breastfeeding

There are different parts to the study and you might not be able to join a certain part if any of the following also apply. You:

• Are not able to have carboplatin
• Have or might have myelodysplastic syndrome (MDS)
• Have or might have acute myeloid leukaemia (AML)
• Have had a biological therapy  as part of a clinical trial in the past 7 weeks
• Have had a blood transfusion in the past 4 months
• Have a blockage of the gut
• Have severe bleeding of the food pipe (oesophagus) or stomach within the 4 weeks of starting treatment
• Are allergic to olaparib or any of its ingredients
• Are allergic to durvalumab or any of its ingredients
• Have had medication that affects the immune system such as steroids within 4 weeks
• Have had a live vaccine  within a month of starting treatment
• Have or have had sarcoidosis
• Have or have had tuberculosis