A trial of AZD6738 and gemcitabine for solid cancers (ATRiUM)

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1

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:

  • leukaemia Open a glossary item
  • lymphoma Open a glossary item
  • myeloma Open a glossary item

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. 

More about this trial

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 laboratory studies Open a glossary item that combining AZD6738 with gemcitabine might work better than gemcitabine only. 

The aims of this trial are to find:

  • the best dose of AZD6738 to give with gemcitabine
  • how acceptable this combination is
  • out about the side effects

Who can enter

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 solid cancer Open a glossary item that:

  • can’t be removed with surgery
  • has spread into the surrounding tissue or to another part of the body and continued to grow while having standard treatment Open a glossary item or you don’t want standard treatment 

And all of the following must apply. You:

  • can do anything apart from heavy physical work (performance status 0 or 1)
  • have cancer that can be seen and measured on a scan Open a glossary item
  • have cancer that a small piece of tissue (biopsy Open a glossary item) can be taken from
  • have satisfactory blood test results
  • are willing to use 2 reliable forms of contraception during the trial and for 6 months after if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

  • have had chemotherapy within 3 weeks of starting treatment
  • have had a targeted drug within 30 days of starting treatment
  • have had immunotherapy Open a glossary itemtreatment within 6 weeks of starting treatment
  • have started treatment with a bisphosphonate Open a glossary itemor denosumab for cancer that has spread to the bone within 5 days of starting treatment
  • have had another cancer in the past 3 years apart from abnormal cells of the cervix Open a glossary item (CIN), non melanoma of skin, Open a glossary item ductal carcinoma in situ Open a glossary item (DCIS), early stage endometrial cancer or any other solid cancer that has been successfully treated and there hasn’t been a sign of it coming back in the past 5 years or more
  • still have any side effects from previous cancer treatment apart from hair loss and mild nerve damage 
  • have cancer that is pressing on your spinal cord causing spinal cord compression Open a glossary item unless there are no symptoms, it is stable and you haven’t needed to take steroids for at least 4 weeks before starting treatment 
  • have cancer spread it the brain or spinal cord unless it has been treated and there is no sign of it getting worse. If you are taking steroids it should be no more than 10mg a day and you have been on a stable dose for at least 4 weeks before the start of trial treatment 
  • have already had a drug that works in the same way that is an ART inhibitor
  • are known to be sensitive to AZD6738, gemcitabine or any of their ingredients

Medical conditions
You cannot join this trial if any of these apply. You:

  • have ataxia telangiectasia Open a glossary item syndrome
  • have had major surgery within 2 weeks of starting treatment
  • still have ongoing side effects from any previous surgery
  • are taking more than 10mg of steroids or another drug that damps down the immune system Open a glossary item within 2 weeks of starting treatment
  • are taking medication that affects the CYP enzymes
  • have had a heart attack, heart failure, unstable angina or a similar heart problem in the past 6 months
  • have low blood pressure
  • have high blood pressure that isn’t controlled by medication
  • can’t swallow tablets or have a problem with your digestive system Open a glossary item that could affect how well your gut absorbs medication
  • have HIV, hepatitis B or hepatitis C
  • have an infection and need to have medication such as antibiotics that reach the whole body (systemic treatment Open a glossary item)
  • have any other medical or mental condition that your doctor or the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

  • are taking any herbal supplements, homeopathic remedies or any similar ‘folk remedies’ 
  • are pregnant or breastfeeding 
     

Trial design

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:

  • every day or
  • every day for 4 days and then 3 days of not taking it 

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. 
 

Hospital visits

You see the doctor to have tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan
  • a small sample of cancer tissue (biopsy)

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.
 

Side effects

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. 

Location

Cambridge

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

Professor Duncan Jodrell

Supported by

AstraZeneca UK

CRUK-Cambridge Centre

Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16601

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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