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

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 08 Aug 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

    • 30 Jul 2018 Planned End Date changed from 1 Jul 2018 to 1 Jan 2019.
    • 30 Jul 2018 Planned primary completion date changed from 1 Jun 2018 to 1 Dec 2018.
    • 08 May 2018 According to an Epizyme media release, French National Agency for Medicines and Health Products Safety (ANSM) has put this trial on hold in first week of May 2018. The company is working with the regulatory authorities to resume enrollment in clinical trials.
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