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An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

Trial Profile

An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Dec 2018

At a glance

  • Drugs Prednisolone (Primary) ; Tazemetostat (Primary) ; Midazolam
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Eisai Co Ltd; Epizyme
  • Most Recent Events

    • 24 Sep 2018 According to an Epizyme media release, the U.S. FDA has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials. The company is now in the process of reopening enrollment in all of its company-sponsored trials in the U.S., including the follicular lymphoma (FL) EZH2 activating mutation cohort of its Phase 2 non-Hodgkin lymphoma trial.
    • 31 Aug 2018 Biomarkers information updated
    • 15 Jun 2018 According to an Epizyme media release, the company will conduct an Investor conference call to discuss interim clinical activity and tolerability data from the study.
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