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

Eisai Co., Ltd.7 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Interventions

TazemetostatDRUG

Tazemetostat tablets.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

Eisai Trial Site

Isehara, Kanagawa, Japan

Eisai Trial Site

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Dose-limiting Toxicities (DLTs)

DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) were defined as: 1) Grade 4 neutropenia for greater than (\>) 7 days; 2) greater than or equal to (\>=) Grade 3 febrile neutropenia; 3) Grade 4 thrombocytopenia and Grade 3 thrombocytopenia with bleeding; 4) Grade 4 anemia or anemia requiring erythrocyte transfusion; 5) \>=Grade 3 nausea, vomiting, or diarrhea that persisted \>7 days despite maximal medical therapy; 6) \>=Grade 3 non-hematological laboratory abnormalities with clinical symptoms that persisted \>7 days; 7) Other Grade 3 toxicity lasting \>7 days or Grade 4 non-hematological toxicity of any duration; 8) Failure to administer \>=75 percent (%) of the planned administration number of study drug in Cycle 1 as a result of treatment-related toxicity. Here, number of participants who had DLT were reported.

Time frame: Cycle 0 and Cycle 1 (Cycle 0=4 days, Cycle 1=28 days)

Secondary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

TEAE was defined as an adverse event (AE) that emerged during time from first dose to 30 days following last dose of drug, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to pretreatment state, when AE was continuous. Number of participants with TEAEs were reported based on their safety assessments of laboratory tests, physical examination, regular measurement of vital signs, body weight, echocardiograms/multigated acquisition (MUGA) scans to assess left ventricular ejection fraction, eastern cooperative oncology group-performance status (ECOG-PS) and electrocardiograms parameter values. SAE was defined as untoward medical occurrence that at any dose resulted in death; was life threatening; resulted in persistent or significant disability; was congenital anomaly or medically important due to other reasons than above mentioned criteria.

Time frame: From the date of first dose up to 30 days after the last dose of study drug (up to 40 months)

Cmax: Maximum Plasma Concentration of Tazemetostat and Its Metabolite ER-897387

Data from ClinicalTrials.gov

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