A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1 Study of Tazemetostat in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

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).

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