GSK525762: a phase 1/2 trial to find the best dose and test the effectiveness of a new targeted drug in people with relapsed or refractory lymphoma or other blood cancers

You might be able to enter this trial if you have lymphoma that has already been treated but needs more treatment and you don't have any other standard treatment options. 

Part 1 of this trial is complete. The trial is recruiting new participants for part 2, but only people with cutaneous (skin) T-cell lymphoma (CTCL) can enter this part of the trial.


Purpose of trial

The aim of the trial is to test whether a new targeted drug, GSK525762, is safe and effective for people with lymphoma or another blood cancer that has relapsed (come back) or didn’t respond (was refractory) to treatment.


Treatments

There are 2 parts to this trial. You may enter at either part 1 or part 2.

  • Part 1 is to find out the highest safe dose of GSK525762. This is done by ‘dose escalation’. Participants are treated in groups of 3. The first 3 participants have the lowest dose. The next 3 have a higher dose. This continues and the participants are monitored closely for side effects. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
  • Part 2 follows on from Part 1 and will test how well the highest safe dose of the study drugs works. People entering this part of the trial all have the same dose of study drugs.

You take GSK525762 as tablets by mouth. Most people take the tablets once a day. Some people might take the tablets twice a day.

You continue to take the trial treatment as long as you are responding well and not having any serious side effects.

The trial is recruiting people with all types of lymphoma, including at least 10 people with double-hit or triple-hit lymphoma.

The trial team may test a sample from a previous biopsy to confirm your diagnosis.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

A total of 180 people are needed for this trial worldwide.

You may be able to enter if:

  • You have relapsed or refractory lymphoma or another type of blood cancer. 
  • You are well enough to look after yourself and to do light work (office work, house work).
  • You can swallow tablets.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use reliable contraception before treatment starts (the doctor can advise how long this is needed for), during treatment and for at least 7 months after treatment if there is any chance of you or your partner becoming pregnant.
  • You are 18 or over.

You will not be able to enter if:

  • You have HIV, hepatitis B, or hepatitis C.
  • You have had an organ transplant.
  • You have had a stem cell transplant in the last 3 months or you haven’t recovered from the side effects of a previous transplant or you have significant graft versus host disease.
  • You have taken immunosuppressive medicines in the last month, except topical (applied to the skin) steroids.
  • You have had another cancer in the last 5 years except certain localised cancers or slow-growing or successfully treated second cancers.
  • You are having other anti-cancer treatment.
  • You’ve had another experimental drug in the 2 weeks before starting the trial treatment; ask your medical team for details.
  • You’ve had major surgery, radiotherapy or antibody therapy in the last 4 weeks.
  • You’ve had certain chemotherapy drugs in the last 6 weeks.
  • You have a severe infection or an infection that is not well controlled.
  • You still have significant side effects from your previous treatment.
  • You have primary central nervous system (CNS) lymphoma or your lymphoma is in your central nervous system (brain and spinal cord) and is causing symptoms or has not been treated.
  • You have significant heart problems.
  • You have had an allergic reaction to a similar drug before.
  • You have coughed up blood in the last 7 days.
  • You have gastrointestinal (digestive system) bleeding or have had major gastrointestinal bleeding in the last 3 months.
  • You have any digestive problems that might mean you can’t absorb the trial treatment well.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov