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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Tazemetostat (Primary) ; Fluconazole; Omeprazole; Repaglinide
  • Indications Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Epizyme

    • Most Recent Events

    • 23 Mar 2021 Status changed from active, no longer recruiting to completed.
    • 21 Sep 2020 Results of integrated safety analysis of tazemetostat using compiled data from 6 trials (NCT01897571, NCT03010982, NCT03028103, NCT02601950, NCT02860286, NCT02875548) presented at the 45th European Society for Medical Oncology Congress
    • 16 Jul 2019 Planned End Date changed from 1 Sep 2019 to 1 Nov 2019.
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