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

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Eisai

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: Tazemetostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03009344
E7438-J081-106

Details and patient eligibility

About

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).

Enrollment

7 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Tazemetostat 800 mg
Experimental group
Description:
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).
Treatment:
Drug: Tazemetostat

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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