
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at AZD6738 and gemcitabine for solid cancers that have spread to find the best dose to give.
A solid cancer is any cancer apart from the blood cancers. The following are blood cancers:
There are 2 parts to this trial. The 1st part is open to people with any type of cancer. We will add the details about the 2nd part when it is open.
Gemcitabine is a chemotherapy drug doctors use to treat many different cancers.
AZD6738 is a targeted drug. It works by blocking messages that identify damaged DNA in cells. It stops the repair of these damaged cells so they can’t copy themselves and grow.
We know from that combining AZD6738 with gemcitabine might work better than gemcitabine only.
The aims of this trial are to find:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join part 1 of this trial if you have a that:
And all of the following must apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
There are 2 parts to this phase 1 trial. In both parts everyone has AZD6738 and gemcitabine.
Only part 1 is open. When part 2 opens we will update the summary to include it.
AZD6738 is a tablet. You take it either:
Your doctor will tell you how many to take and how often.
You have gemcitabine as a drip into a vein. You have it once a week for 3 weeks and then not have it for 2 weeks.
You have your first dose 3 days after starting AZD6738.
You continue to have treatment as long as it is helping and the side effects aren’t too bad.
Part 1
In this part the trial team need up to 40 people to take part.
The first few people will have a low dose of AZD6738 with their gemcitabine. If all goes well the next few will have a higher dose of AZD6738 with their gemcitabine. This goes on until the safest dose of AZD6738 to give with gemcitabine is found. This is a dose escalation study.
You have a treatment diary to take home. You fill it in every time you have a tablet. You must bring this diary with you when you go to the hospital.
Blood and tissue samples
The will ask for your permission to get a small piece of cancer tissue from when you were first diagnosed.
They will take a small piece of your cancer (biopsy) at 3 different times during the trial if it is safe and possible to do.
You see the doctor to have tests before taking part. These tests include:
During treatment you see the doctor every week for blood tests and to see how you are.
You have regular heart traces during the first 4 weeks of treatment and then every 4 weeks.
You have a CT scan every 8 weeks.
You see the doctor at the end of treatment and then every 6 weeks for blood tests and to see how you are. You have a CT scan every 12 weeks.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
AZD6738 is a new drug and there might be side effects we don’t know about yet. The common side effects of AZD6738 include:
We have information about the side effects of gemcitabine.
Your doctor or a member of the trial team will talk to you about the side effects of these treatments before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Duncan Jodrell
AstraZeneca UK
CRUK-Cambridge Centre
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.