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

NCT ID: NCT03009344

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2020-06-17

Brief 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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tazemetostat 800 mg

Participants will receive oral tazemetostat at a starting dose of 800 milligrams (mg) as a single dose (Cycle 0) and 800 mg twice a day as continuous dosing (Cycle 1 and later) (Cycle 0 duration=4 days) (Cycle 1 and later duration= 28 days).

Group Type: EXPERIMENTAL

Tazemetostat

Intervention Type: DRUG

Tazemetostat tablets.

Interventions

Tazemetostat

Tazemetostat tablets.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site

Isehara, Kanagawa, Japan

Eisai Trial Site

Chuo-ku, Tokyo, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

E7438-J081-106

Identifier Type: -

Identifier Source: org_study_id