A study looking at AZD5363 for cancer (OAK)

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 1

This study looked at capivasertib (AZD5363) for solid tumours that continued to grow despite all other standard treatments.

More about this trial

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.

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

Capivasertib was first made as a capsule and these are difficult to make. So the makers designed a tablet. They knew from laboratory studies that the tablet works in a similar way as the capsule. But the researchers needed to find out if this was the same when given to people.

The researchers compared the capivasertib tablet with the capivasertib capsule to find out:

how well the tablet worked
how safe the tablet is
if it was better to take capivasertib with food or not

This study took place between December 2013 and July 2015. The results were published in March 2018.

Summary of results

The team found that the tablet worked as well as the capsule and that the side effects were generally the same as the capsule.

About this study
This was a phase 1 study. There were 2 parts to this study.

When part A was completed another group of people were asked to join part B.

In part A the team looked at how well the tablet and the capsule were absorbed by the body.

In part B the team wanted to know if having capivasertib with food affected how well it was absorbed by the body. They did this by measuring the amount of capivasertib in the blood over a certain period of time.

Results of part A
18 people took part. Everyone took the capivasertib tablet for 1 week and then they had the capsule for the following week.

In both weeks, they took capivasertib in the morning and the evening for 4 days. And then they had no treatment for 3 days. They took it on an empty stomach. That is no food from 2 hours before taking the tablet and no food to 1 hour after. This is the standard way to take capivasertib.

On the 4th day of week 1 and week 2 a number of blood samples were taken before and after taking capivasertib.

The researchers compared the results of the blood samples from week 1 and week 2. This was to find out how well the capivasertib tablet and capsule were absorbed. And what happened to capivasertib in the blood.

They found that the tablet was absorbed faster than the capsule. But the total amount of capivasertib absorbed by the body from the tablet and the capsule and detected in the blood over a certain period of time was similar.

Results of part B
12 people took part. Everyone took capivasertib as a tablet in the morning and the evening for 4 days. And then they had no treatment for 3 days.

In week 1, for 3 days they took the tablet 2 hours before food and no food for 1 hour after taking it. This is the standard way of taking capivasertib.

On the 4th day they took the tablet after fasting overnight (not eating for at least 8 hours). And then they couldn’t eat for 4 hours after taking the tablet.

In week 2, for 3 days they took the tablet according to the standard way.

On the 4th day, they took the morning tablet with their breakfast after fasting overnight. And then they couldn’t have anything to eat for 4 hours after taking the tablet.

Everyone’s breakfast contained the same amount and type of food.

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On the 4th day of each week the team took a number of blood samples before and after taking the tablet.

The researchers compared the results of the blood samples from week 1 and week 2 to find out how well capivasertib was absorbed and circulated throughout the body.

They found that when the tablet was taken with food it took longer for the drug to be absorbed by the body and that the rate it was absorbed was slower.

This meant compared to taking the tablet after fasting overnight it took longer for the maximum amount of capivasertib to be circulating through the body.

Side effects

Part A

During week 1, when people were taking the tablet, the most common reported side effects included:

diarrhoea
a raised amount of glucose (sugar) in the blood
feeling sick

During week 2, when they were taking the capsule the most common side effects reported included:

diarrhoea
a raised amount of glucose in the blood
a drop in red blood cells
a high temperature

Part B

During week 1, when the capivasertib tablet was taken on an empty stomach the most common side effect reported was diarrhoea.

During week 2, when the tablet was taken with food the most common side effects reported included:

diarrhoea
skin rash

Conclusion

The team concluded that the tablet and capsule were:

absorbed by the body in a similar way and time
the side effects were similar

They also concluded that food didn’t affect the amount of capivasertib the body absorbed. But having it with food did affect the rate at which it was absorbed. And this affected how long it took to reach the maximum dose of capivasertib circulating through the body.

The team said that it isn’t yet known if having capivasertib with food will affect how well it works. And until more information is known they recommend that capivasertib should continue to be taken on an empty stomach (no food within 2 hours before taking the tablet and no food for an hour after).

Where this information comes from

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item

) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.