A trial looking at AZD6738 with radiotherapy for advanced solid tumours (PATRIOT)

Everyone in this trial had ceralasertib. It is a tablet you take twice a day. A total of 67 people joined. 

Part 1
24 people joined this part. To find the best dose, the first few people had a small dose of ceralasertib. As they didn’t have any bad side effects, the next few had a higher dose. And so on, until the researchers found the highest dose they could give safely. 

Part 2
Of the 43 people who joined this part, 41 had at least 1 dose of ceralasertib. 2 people didn’t start treatment because their cancer got worse before starting. 

The trial team looked at whether it was best to have ceralasertib:

• every day or
• take it for 2 weeks daily then 2 weeks of not taking it 

After about 2 years of treatment the team looked at how well ceralasertib worked. They found that for:

• 5 people their cancer had shrunk – a partial response
• 34 people their cancer had stayed the same – stable disease. This included 1 person with cancer that might have shrunk but this was not confirmed.
• 27 people their cancer continued to grow

The team are writing up more results. When they come available, we will update this summary.

Side effects
The team looked at how many people had stopped treatment or their doctors reduced the dose due to the side effects. They found that it was:

• half of the people who had ceralasertib everyday
• around a third who had ceralasertib for 2 weeks then 2 weeks not having it

The most common side effects were:

• a drop in blood cells causing an increased risk of infection, bleeding, bruising and tiredness
• feeling or being sick
• tiredness (fatigue)
• loss of appetite
• constipation or diarrhoea

Conclusion
The team concluded that the best dose of ceralasertib is 160mg twice a day for 2 weeks then 2 weeks of not having ceralasertib and so on.

They recommend that this is the dose to give in a phase 2 trial of ceralasertib. 

Researcher teams are doing phase 1 , phase 2 and phase 3 trials to look at ceralasertib on its own or in combination with other drugs for advanced solid cancers. 

The team also found that ceralasertib worked better for cancers that were inflamed. They identified a number of substances (biomarkers ) in the different cancers that could help tell doctors how well ceralasertib is working. 

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Durable responses to ATR inhibition with ceralasertib in tumours with genomic defects and high inflammation
M T Dillon and others
The Journal of Clinical Investigation, 202. Volume 134, issue 2, pages 1 to 14

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.