ASTX660: a phase 1/2 trial to find the best dose and test the effectiveness of a new targeted drug in people with solid tumours or lymphoma

This trial is testing a new drug for people with lymphoma or solid tumours.

Note: This trial is now only recruiting participants with skin (cutaneous)
T-cell lymphoma and peripheral T-cell lymphoma.


Purpose of trial

The aim of this trial is to test whether ASTX660, a new targeted drug, is safe and effective when taken on its own for people with advanced-stage (widespread) solid tumours or lymphomas who have no standard treatment options. The trial aims to find out:

  • the best dose of ASTX660 
  • the side effects of ASTX660
  • if ASTX660 can reduce the cancer.

Treatments

ASTX660 works by blocking the activity of certain proteins that help cancer cells to survive. These proteins are found at high levels in many types of cancer cells. Blocking the activity of the proteins can cause cancer cells to die. 

Everyone in this trial has ASTX660. The trial is in 2 parts. In the first part, different doses of ASTX660 were tested to find the best dose. Part 1 has been completed. In part 2, everyone has the dose of ASTX660 selected in part 1. In this part of the trial, people with certain types of lymphoma and other cancers are put into groups to see how well the treatment works for each group.

People with diffuse large B-cell lymphoma (DLBCL), T-cell lymphomas and cutaneous (skin) T-cell lymphoma are being recruited for part 2 of the trial.

You take ASTX660 orally as a tablet. Each cycle of treatment is 28 days. In each cycle you have:

  • ASTX660 once a day for 7 days (days 1–7)
  • no treatment for 7 days (days 8–14)
  • ASTX660 once a day for 7 days (days 15–21)
  • no treatment for 7 days (days 22–28).

You continue to have treatment for 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. Note: this information is for people with lymphoma. Different factors may apply to people with other types of cancer.

200 people are needed for this trial.

You may be able to enter if:

  • You have diffuse large B-cell lymphoma or T-cell lymphoma and no standard treatment options.
  • A sample of a biopsy of your lymphoma is available or you are willing to have a fresh biopsy taken.
  • You are well enough to take part in the trial.
  • Your blood and organ function test results are satisfactory.
  • You might be fertile and are willing to use at least 2 reliable methods of contraception during the trial and for at least 3 months after finishing treatment.
  • You are 18 or over.

You will not be able to enter the trial if:

  • You have had a bad reaction to ASTX660 or any of its ingredients before.
  • Your lymphoma is in your brain, unless it is not growing or has been previously treated.
  • Your doctor thinks any other conditions you have make it unsafe for you to take part in the study.
  • You have any conditions that mean the trial treatment might not be properly absorbed.
  • You have heart problems.
  • You have significant nerve damage (neuropathy – part 1 only).
  • You have had another anti-cancer treatment in the last 2 to 4 weeks, depending on which treatment you had. 
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clincialtrials.gov

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