STARTRK-2: a phase 2 trial testing a newer drug, entrectinib, in people with solid tumours, including anaplastic large cell lymphoma

People with different types of cancer are being recruited for this trial, but this summary only applies to people with lymphoma.


Purpose of trial

The aim of this trial is to test whether entrectinib on its own is safe and effective for people with advanced-stage (widespread) solid tumours with certain genetic changes. This trial is including people with anaplastic large cell lymphoma (ALCL).


Treatments

Entrectinib blocks signals in cells, particularly in cells with certain genetic changes. Blocking these signals can prevent cancer cells from multiplying. Some people with anaplastic large cell lymphoma have genetic changes (ALK mutations) that might make the lymphoma susceptible to entrectinib.

A sample of your biopsy is sent for genetic testing to look for the ALK mutation. It can take several weeks for the result to be available. You can only enter the study if the lymphoma cells in your biopsy have the ALK mutation.

Everyone in this trial has entrectinib orally (by mouth) once a day, every day. You keep taking entrectinib for as long as it is benefiting you.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you. Note: this information is for people with lymphoma. Different factors may apply to people with other types of cancer.

The trial is recruiting around 300 people with different types of cancer.

You may be able to enter if:

  • You have anaplastic large cell lymphoma (ALCL) with an ALK gene rearrangement.
  • A sample of a biopsy of your lymphoma is available or you are willing to have a fresh biopsy taken.
  • At least 2 weeks or 5 half-lives (a half-life is the time it takes your body to get rid of half of the amount of drug you took) have passed since you had any chemotherapy or targeted therapy.
  • At least 4 weeks have passed since you had any antibody therapy.
  • At least 2 weeks have passed since you had any radiotherapy treatment.
  • You are well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.
  • Your cancer is measurable with the tests used in the trial.
  • You can swallow the trial treatment.
  • You are 18 or over.

You will not be able to enter if:

  • You have been treated with certain targeted treatments before.
  • You are taking another investigational treatment.
  • You have had a previous cancer that might affect the results of the trial.
  • You have not completely recovered from any previous surgery.
  • You have a prolonged QTc interval (a change on an electrocardiogram, which looks at your heart’s electrical activity) or any other risk factors for a heart problem called ‘torsade de pointes’.
  • You have peripheral neuropathy unless this is mild.
  • You have a current active infection.
  • You have any digestive problems that might mean you cannot properly absorb the study treatment.
  • You have certain lung problems.

Further information

More information about this trial is available at clinicaltrials.gov