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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 (NCT03028103)

This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
  • Drug: Tazemetostat
    Tazemetostat is a selective oral small molecule inhibitor of EZH2
    • EPZ-6438, E7438
  • Drug: Fluconazole
    200mg will be orally administered QD for 4 days in order to determine CYP3A4 inhibition when administered concomitantly with tazemetostat
    • Drug: Omeprazole
      Using omeprazole as a probe substrate, 20mg will be orally administered for a total of 5 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C19. Omeprazole is also being used to determine the effect of increased gastric pH on metabolism of tazemetostat.
      • Drug: Repaglinide
        Using repaglinide as a probe substrate, 25mg will be orally administered for a total of 2 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C8.
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No

        3 locations

        United States (3)
        • University of Arizona Cancer Center
          recruiting
          Tucson, Arizona, United States, 85719
        • Moffitt Cancer Center
          not yet recruiting
          Tampa, Florida, United States, 33612
        • Columbia University Medical Center
          recruiting
          New York, New York, United States, 10032
        Status:
        recruiting
        Type:
        Interventional
        Phase:
        Start:
        26 March, 2017
        Updated:
        04 December, 2017
        Participants:
        28
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