Epizyme EZH202 - Adult

• Research type

  Research Study

• Full title

  A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumours or Relapsed/Refractory Synovial Sarcoma

• IRAS ID

  191084

• Contact name

  Robin Jones

• Contact email

  Robin.jones@rmh.nhs.uk

• Sponsor organisation

  Epizyme, Inc

• Eudract number

  2015-002469-41

• Clinicaltrials.gov Identifier

  NCT02601950

• Clinicaltrials.gov Identifier

  124608, IND Number

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  The purpose of this study is to measure effectiveness (e.g. response rate or progression free survival rate) of the experimental study drug (tazemetostat) in adult patients with Rhabdoid Tumours, Synovial Sarcomas and other rare tumours that lack the INI1 or SMARCA4 protein. Patients must have received approved therapy for their cancer in the past that did not work or have a tumour for which there is no standard therapy available and must have no other options for effective therapy.\nTazemetostat is a selective small molecule inhibitor of histone-lysine methyltransferase enzyme EZH2. Sponsor research has shown that inhibition of EZH2 with tazemetostat results in the death of EZH2-dependent genetically defined cancer cells. For example, laboratory studies have demonstrated that tazemetostat inhibits the growth of cancer cells lacking the INI1 protein in vitro and in vivo. Tazemetostat has been shown to provide clinical benefit in patients with Malignant Rhabdoid Tumours in terms of disease progression and remission. To date no patients with synovial sarcoma have shown significant response but as synovial sarcomas also display decreased expression of the INI1 protein it is hoped that further testing will show results similar to those seen in MRT patients.\nAfter screening, eligible patients will be assigned to 3 different cohorts (depending on their tumour type): Cohort 1: Rhabdoid tumours (INI1- or SMARCA4-negative), Cohort 2: relapsed or refractory synovial sarcoma with SS18-SSX rearrangement, Cohort 3: Other INI1-deficient tumours. (all patients will take tazemetostat twice daily, with tumour assessment every 8 weeks).\nPatients will remain on the study for as long as they are showing no serious adverse effects or disease progression and their study doctor believes they will have clinical benefit from treatment.\nEpizyme Inc, is sponsoring this study; approximately 90 patients (aged ≥16 years) will be recruited into the study at locations worldwide.\n

  Summary of Results
  Treatment with tazemetostat was less effective in participants in Groups 1, 3, 4 and 7, compared to participants in Groups 5 and 6.
  15% of participants in Group 2 had tumours that did not get worse after 16 weeks of treatment. In this study, no new safety concerns were identified following treatment with tazemetostat in Group

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• REC name

  London - Westminster Research Ethics Committee

• REC reference

  16/LO/0242

• Date of REC Opinion

  18 Apr 2016

• REC opinion

  Further Information Favourable Opinion