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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Oct 2019

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At a glance

  • Drugs Tazemetostat (Primary)
  • Indications Adenocarcinoma; Chondrosarcoma; Chordoma; Peripheral nervous system neoplasms; Renal cell carcinoma; Rhabdoid tumour; Sarcoma; Solid tumours; Synovial sarcoma
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Epizyme
  • Most Recent Events

    • 25 Jul 2019 According to an Epizyme media release, the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for accelerated approval of tazemetostat. Epizyme has proposed an indication of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 23, 2020.
    • 17 Jun 2019 Planned End Date changed from 1 Jun 2019 to 1 Feb 2022.
    • 17 Jun 2019 Planned primary completion date changed from 1 Jun 2019 to 1 Jan 2022.
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