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

• Status: Completed
• Trial end date: 2020-06-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.

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