A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Condition: Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Tazemetostat
Intervention description: Tazemetostat tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: relapsed or refractory B-cell non-Hodgkin's lymphoma; tazemetostat; Japan; E7438

Summary:

      This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability,
      safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants
      with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma

          -  Participant who has measurable disease

          -  Participant who had previous therapy with systemic chemotherapy and/or antibody
             therapy

          -  Participant who had progressive disease (PD) or did not have a response (complete
             response [CR] or partial response [PR]) in previous systemic therapy, or relapsed or
             progressed after previous systemic therapy

          -  Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
             1

          -  Participant with life expectancy of ≥3 months from starting study drug administration

          -  Participant with adequate renal, bone marrow, and liver function

          -  Participant with left ventricular ejection fraction (LVEF) > 50%

          -  Male and female participant ≥20 years of age at the time of informed consent

          -  Participant who has provided written consent to participate in the study

        Exclusion Criteria:

          -  Participant with prior exposure to EZH2 inhibitor

          -  Participant with a history or a presence of central nerves invasion

          -  Participant with allogeneic stem cell transplantation

          -  Participant with medical need for the continued use of potent or moderate inhibitors
             of CYP3A or P-gp, or potent or moderate inducer of CYP3A (including St. John's wort).

          -  Participant with significant cardiovascular impairment

          -  Participant with prolongation of corrected QT interval using Fridericia's formula
             (QTcF) to > 480 milliseconds (msec)

          -  Participant with venous thrombosis or pulmonary embolism within the last 3 months
             before starting study drug

          -  Participant with complications of hepatic cirrhosis, interstitial pneumonia, or
             pulmonary fibrosis

          -  Participant with active infection requiring systemic therapy

          -  Women of childbearing potential or man of impregnate potential who don't agree to use
             a medically effective method for contraception for periods from before informed
             consent to during the clinical study and 30 days later from last administration of
             study drug

          -  Woman who are pregnant or breastfeeding

          -  Participant who were deemed as inappropriate to participate in the study by the
             investigator or sub-investigator