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An Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize the Effects of a Moderate CYP3A Inhibitor on the Pharmacokinetics of Tazemetostat (EPZ-6438) (Part A), the Effects of Tazemetostat on the Pharmacokinetics of CYP2C8 and CYP2C19 Substrates, and the Effect of Increased Gastric pH on the Pharmacokinetics of Tazemetostat (Part B) in Subjects With B-cell Lymphoma or Advanced Solid Tumors

Trial Profile

An Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize the Effects of a Moderate CYP3A Inhibitor on the Pharmacokinetics of Tazemetostat (EPZ-6438) (Part A), the Effects of Tazemetostat on the Pharmacokinetics of CYP2C8 and CYP2C19 Substrates, and the Effect of Increased Gastric pH on the Pharmacokinetics of Tazemetostat (Part B) in Subjects With B-cell Lymphoma or Advanced Solid Tumors

Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Dec 2018

At a glance

  • Drugs Tazemetostat (Primary) ; Fluconazole; Omeprazole; Repaglinide
  • Indications Diffuse large B cell lymphoma; Mantle-cell lymphoma; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Epizyme
  • Most Recent Events

    • 07 Nov 2018 Planned End Date changed from 1 Jan 2019 to 1 Sep 2019.
    • 07 Nov 2018 Planned primary completion date changed from 1 Dec 2018 to 1 Aug 2019.
    • 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.
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