This is a phase 1 trial. It is in 2 parts. For part 1 the researchers need about 12 to18 people to take part. For part 2 they will need about 40 people.
The aim of the first part of the trial is to find out the best dose of AZD5363 that you can have with olaparib. You will be put into 1 of 2 groups. People in both groups take olaparib twice a day throughout the trial. Then
- One group have AZD5363 twice a day for 4 days each week (with 3 days off)
- One group have AZD5363 twice a day for 2 days each week (with 5 days off)
Olaparib is a tablet and AZD5363 is a capsule. From November 2014 all patients having AZD5363 will have this as a tablet. Your dose of AZD5363 will be increased twice if you don’t have any bad side effects.
Once the researchers have established the best dose of AZD5363, they will move into the second part of the trial. The aim of this part is to find out more about how the combination of the 2 drugs works. The researchers will be looking for people with certain gene changes, including people who have changes to genes called BRCA1 or BRCA2.
The researchers will work out the best way to take AZD5363 in the first part of the trial. If you join the second part, the researchers will tell you when to take both drugs.
The researchers may ask you to have a biopsy before the treatment starts and again a couple of weeks after starting treatment. These samples may help researchers learn more about how the drugs work. If you don’t wish to have these biopsies, you don’t have to. You can still take part in the trial.
You can have treatment
- For as long as it is helping you and your cancer has not grown
- Until you decide you don’t want to continue with the trial
- Until your trial doctor feels its best for you to stop the trial
You see the trial team and have some tests before you start treatment. The tests include
Before you have your first dose of the drugs, your doctor will pluck 4 of your eyebrow hairs so they can test the hair follicle (the base of the hair). The doctors may take more hair follicles during treatment to check the levels of the drugs in your body. If you do not have enough eyebrow hair you can still take part in the trial.
You will need to go to hospital regularly during treatment. This will include some overnight stays to have blood tests at different times during the day. During your hospital visits you will also have a physical examination and blood and urine tests to check your general health.
You have a heart trace (ECG) on the 1st day of treatment, at the end of the 1st week, then every 3 weeks.
You have a heart scan (an echocardiogram or MUGA scan) after 3 weeks.
If you agreed to have a sample of your cancer (biopsy ) taken just before the start of the trial, you may also have a second biopsy. This will be a couple of weeks after starting treatment.
About every 9 weeks you will have a CT or MRI scan so that the doctors can measure your cancer. You may also have some blood tests to check for tumour markers .
AZD5363 can increase the levels of sugar in your body. The trial team will ask you to do a urine test twice a week to check for sugar.
When you finish the trial treatment you go to hospital about 4 weeks later for a check up and a repeat of the tests you had before you started treatment.