A trial of entrectinib for advanced solid tumours (STARTRK-2)

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.

You might be able to join this trial if all of the following apply.

• You have a solid tumour that has spread into surrounding tissues or elsewhere in the body or you have anaplastic large cell lymphoma
• There is a sample of tissue (biopsy ) available for the trial team to do some tests on that show your cancer cells have certain gene changes, or you are willing to have a new sample taken
• Your cancer cells have gene changes that include NTRK1/2/3 or ROSI 
• Your cancer can be seen and measured on a scan
• You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
• You have satisfactory blood test results
• You are at least 18 years old

You cannot join this trial if any of these apply. 

Cancer related

You:

• Have cancer that has spread to your brain or the membranes surrounding the brain (leptomeningeal disease). But you might be able to join if you have had treatment for this or the cancer isn’t causing symptoms. 
• Have already had treatment such as crizotinib, ceritinib, alectinib, lorlatinib or larotrectinib (LOXO-101) that targets the same gene changes as entrectinib in the cancer cells
• Have had chemotherapy or a targeted cancer drug that has not completely cleared your body  
• Have had monoclonal antibody  treatment in the last 4 weeks
• Have had radiotherapy within 14 days of starting trial treatment or you finished stereotactic radiosurgery to the brain within 7 days
• Are having treatment as part of another experimental trial
• Have had another cancer in the past that might interfere with how entrectinib works

Medical conditions

You:

• Haven’t fully recovered from surgery
• Have problems with your heart, such as a heart attack in the last 3 months, angina that is not well controlled, an abnormal heart rhythm that needs treatment, congestive heart failure or a heart artery bypass operation
• Have had a stroke or a mini stoke (TIA) in the last 3 months
• Have extra risk factors for a heart condition called torsade de pointes such as a family history of an abnormal heart rhythm called long QT syndrome
• Have a lung condition called interstitial lung disease or inflammation in the lung caused by having a targeted cancer drug called a tyrosine kinase inhibitor
• Have had problems with your digestive system  such as Crohn’s disease or ulcerative colitis that might interfere with how you absorb the trial drug
• Have a history of or there is someone in your family with a history of bone disease 
• Have significant numbness or tingling in your hands or feet (peripheral neuropathy )
• Have an infection that might affect how entrectinib works
• Have HIV
• Have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

You:

• Can’t swallow capsules without chewing, crushing or opening them
• Are pregnant or breastfeeding