Phase1 Study Of Tazemetostat To Determine How the Body Processes it

• Research type

  Research Study

• Full title

  A Phase I, Open-label Multi-dose Two-Part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor on the Steady-State Pharmacokinetics of Tazemetostat (EPZ-6438), and the Effects of a Strong CYP3A4 Inducer on the Steady-State Pharmacokinetics of Tazemetostat in Subjects with Advanced Malignancies

• IRAS ID

  287444

• Contact name

  Robin Jones

• Contact email

  robin.jones@rmh.nhs.uk

• Sponsor organisation

  Epizyme, Inc.

• Eudract number

  2020-002669-33

• Duration of Study in the UK

  2 years, 5 months, 2 days

• Research summary

  Tazemetostat (EPZ-6438) is a highly selective small molecule inhibitor of the histone-lysine methyltransferase enzyme (a protein) EZH2 and is being developed as a treatment for patients with blood, bone marrow and lymph cancers and/or tumours.

  This is a global Phase I 2-part, multi-center, open-label (the patient and research team will know what drug the patient receives) clinical trial, designed to analyse the pharmacokinetics (metabolism) and drug-drug interaction of oral Tazemetostat when CYP3A4 (main Tazemetostat metabolising protein) is inhibited by itraconazole (Part 1) or induced by rifampin (Part 2) in humans.

  Approximately 40 subjects will be enrolled in the study across 24 study centres worldwide.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  21/SC/0053

• Date of REC Opinion

  4 Jun 2021

• REC opinion

  Further Information Favourable Opinion