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

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 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 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
• have cancer that a small piece of tissue (biopsy ) 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 treatment within 6 weeks of starting treatment
• have started treatment with a bisphosphonate or 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  (CIN), non melanoma of skin,  ductal carcinoma in situ (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  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  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  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 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 )
• 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