A study looking at AZD5363 for cancer (OAK)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types




Phase 1

This study is looking at a new drug called AZD5363 for solid tumours Open a glossary item that have continued to grow despite all other standard treatments Open a glossary item.

Normally, cells in the body divide and grow in an organised way. But in cancer cells, some important proteins which help control cell growth start to behave abnormally. So the cells start to grow and divide more quickly.

AZD5363 works by blocking one of these proteins. Researchers are continuing to collect information about how well AZD5363 works and how safe it is.

AZD5363 is a capsule and these are difficult to make. So the makers have designed a tablet. We know from laboratory studies Open a glossary item that the tablet works in a similar way as the capsule. But the researchers need to find out if this is so when given to people.

The researchers want to compare the AZD5363 tablet with the AZD5363 capsule to find out how well the tablet works and how safe the tablet is.

Who can enter

You may be able to enter this trial if

  • You have a solid tumour Open a glossary item (apart from lymphoma) that has got worse or came back despite having standard treatment Open a glossary item, or where there is no standard treatment available
  • Your cancer has not got worse in the past 2 weeks
  • You have at least 1 area of cancer that can be easily seen on a CT scan, or an MRI scan, or an X-ray and the team will be able to monitor it throughout the study
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • Your cancer has spread to your brain or spine. If you have no symptoms and you have not had steroids for the last month you may be able to take part
  • You have had treatment with the chemotherapy drugs nitrosoureas Open a glossary item or mitomycin C in the last 6 weeks
  • You have had treatment as part of another clinical trial in the last month
  • You have had any other anti cancer medicines in the last 3 weeks (apart from certain hormone therapy for prostate cancer, such as Zoladex and Prostap)
  • You take any other medicines that affects body proteins called cytochrome P enzymes in last 2 weeks, or 3 weeks if you have taken St John’s Wort (you can ask your doctor about this)
  • You have had major surgery in the last month. If you have had minor surgery to put in a central line Open a glossary item or portacath Open a glossary item, you can still take part
  • You have had radiotherapy to treat a large area of your body in the last month
  • You have any condition that affects how your body uses sugar, for example diabetes Open a glossary item (you can check this with your doctor)
  • You are still having side effects from previous cancer treatment, apart from hair loss
  • You have HIV, hepatitis B or hepatitis C or have had a positive test for any of these
  • You have low blood pressure that is uncontrolled (your readings are below 90 / 50)
  • You have had certain heart problems in the last 6 months
  • You have any condition which would stop you from swallowing or absorbing the study medication
  • You have any other condition that would make you unwell, or affect the results of this study
  • You are allergic, or sensitive, to anything in AZD5363 or similar drugs
  • You have already had AZD5363 in another clinical trial

There are 2 parts in this study. For part B, you should also be willing not to eat overnight and for at least 4 hours after taking AZD5363 on 2 occasions. Also for Part B, you cannot take part if you have a problem with your digestive system Open a glossary item that could affect you being able to eat the meal that is part of this study.

Trial design

Everyone taking part will have AZD5363.

You have AZD5363 either as a tablet, capsule, or both. You take it on an empty stomach. You take it 2 hours before you eat and you must not eat for 1 hour after taking them. You take AZD5363 twice a day, about 12 hours apart for 4 days each week.

There are 2 parts to this study.

In part A, your first 8 doses of AZD5363 is a tablet. After this you have it as a capsule. After a while your doctor may talk to you about switching back to the tablet.

In part B, you have AZD5363 as a tablet. In this part the researchers want to find out what effect food has on how your body absorbs the AZD5363 tablet.

During the first week you take AZD5363 as usual apart from the 4th day. On the 4th day you go to the hospital after not eating overnight and not having breakfast. The researchers will take some blood samples. You take your tablet and don’t eat for another 4 hours afterwards. Then they take some more blood samples.

During the 2nd week, you take your tablet as usual apart from the 4th day. On the 4th day you go the hospital after not eating overnight and not having breakfast. The researcher will take some blood samples and then give you a meal to eat. You take your tablet 30 minutes after eating and then don’t eat for another 4 hours. They will then take some more blood samples.

After this you take AZD5363 as usual for 4 days each week.

While taking AZD5363, you may sometime need to stay overnight in the hospital. Your doctor will talk to you about this.

You continue taking AZD5363 as long as it is helping you and there aren’t any bad side effects.

For as long as you are taking AZD5363, and for 3 months afterwards, you should avoid being in the sun too much, and using sun beds. If you do go outside into the sun, you should use sunglasses and sun protection.

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. They will also ask for another sample if your cancer gets worse. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this study. These tests include

  • A physical examination
  • 3 Heart traces (ECG Open a glossary item)
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • Blood tests and urine tests
  • CT scan or MRI scan

When you take your very first dose of AZD5363, you have a number of tests including

  • Blood pressure
  • Physical examination
  • 3 heart traces
  • Blood and urine tests
  • Taking a couple of small samples of hair from your eyebrows

At the start of the study, you have a large number of blood tests. The doctor will put a small plastic needle into a vein in your arm, to take the blood from. So you will not be pricked lots of times with a needle.

Side effects

AZD5363 is a new drug and there may be side effects we don’t know about yet. The side effects reported so far include

  • Changes to levels of sugar, insulin and fat in your blood
  • Skin rash
  • Diarrhoea
  • Change to the strength of your heartbeat and blood pressure
  • Changes to your liver and how it works
  • Changes to some of the glands Open a glossary item that control hormone Open a glossary item levels in your body (thyroid Open a glossary item, pituitary Open a glossary item and adrenal glands Open a glossary item)
  • Changes to how your womb and ovaries Open a glossary item work (if you are a woman), or to your testicles Open a glossary item (if you are a man), which may affect your chance of having children

When you have your eyebrows plucked you may have pain, redness and rarely, infection.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Udai Banerji

Supported by

Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 7074

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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