Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : E7438
INN of investigational material : tazemetostat
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (2)Participant who has measurable disease (3)Participant who had previous therapy with systemic chemotherapy and/or antibody therapy (4)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 (5)Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (6)Participant with life expectancy of >=3 months from starting study drug administration (7)Participant with adequate renal, bone marrow, and liver function (8)Participant with left ventricular ejection fraction (LVEF) > 50% (9)Male and female participant >=20 years of age at the time of informed consent (10)Participant who has provided written consent to participate in the study
Exclusion criteria
Exclusion criteria: (1)Participant with prior exposure to EZH2 inhibitor (2)Participant with a history or a presence of central nerves invasion (3)Participant with allogeneic stem cell transplantation (4)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). (5)Participant with significant cardiovascular impairment (6)Participant with prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480 milliseconds (msec) (7)Participant with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug (8)Participant with complications of hepatic cirrhosis, interstitial pneumonia, or pulmonary fibrosis (9)Participant with active infection requiring systemic therapy (10)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 (11)Woman who are pregnant or breastfeeding (12)Participant who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Dose-limiting toxicity (DLT) of tazemetostat during Cycles 0 and 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics - | — |
Countries
Japan
Outcome results
None listed