TAK-659: a phase 1 trial testing a new drug called TAK-659 for people with non-Hodgkin lymphoma that has come back or not responded to treatment

This trial is now closed. It is no longer recruiting participants.


Purpose of trial

This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment but the trial will give important information about this new treatment, which could help other people in the future.

The aim of this trial is to find out more about using a new treatment called TAK-659 for people with lymphoma. The trial aims to find:

  • the best dose to use
  • about the side effects
  • how well the treatment works
  • how the treatment behaves in the body.

Treatments

TAK-659 is a targeted drug that works by blocking the action of a protein called syk. The syk protein is part of a signalling pathway that controls how B cells grow and develop. In lymphoma, abnormal cells grow in an uncontrolled way. Blocking this protein in lymphoma cells with TAK-659 could cause them to die or control their growth.

The trial is in two parts.

TAK-659 is a tablet that you take once a day. In this trial, you can continue to take the drug for up to a year as long as it is benefitting you.


Who can enter

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

Around 182 people are needed for this trial.

You may be able to enter if:

  • Your lymphoma is measurable by the tests used in the trial.
  • You are over 18.

AND

For Part 1 of the trial:

  • You have lymphoma that is no longer responding to treatment.

For Part 2 of the trial:

  • You have chronic lymphocytic leukaemia, DLBCL, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma (Waldenström macroglobulinemia), marginal zone lymphoma, mantle cell lymphoma or PTLD.
  • Your lymphoma has not responded to, or has come back after at least one other type of treatment.
  • You are well enough to look after yourself and manage light work.
  • You and your partner are willing to use reliable contraception, from a month before treatment until 6 months after, if there is any chance of pregnancy. Women must use two methods of contraception and men must use condoms.
  • Your blood and other health test results are satisfactory.
  • You have previously had at least one course of treatment for your lymphoma.

You will not be able to enter if:

  • You have had a donor (allogeneic) stem cell transplant (unless you have post-transplant lymphoproliferative disorder [PTLD]).
  • You have had a transplant using your own stem cells (autologous) within the past 6 months (unless you have PTLD).

AND

For Part 1 of the trial:

  • You have Waldenstrom’s macroglobulinaemia or a lymphoma that started in your brain or spinal cord (primary CNS lymphoma).

For Part 2 of the trial:

  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You have any health problems that your doctor thinks might make it unsafe for you to have the study treatment. You still have significant side effects from your previous treatment.
  • You can’t swallow tablets or capsules.
  • You’ve had surgery in the last 2 weeks.
  • You have any other lymphoma treatment within 4 weeks of starting the study treatment.
  • You have had another cancer in the past 2 years.
  • You have taken high dose steroids to treat your lymphoma within a week of starting the study treatment.
  • You are taking certain other drugs that might interfere with the study treatment.
  • You have HIV, hepatitis C virus or hepatitis B virus.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov.