JPRN-jRCT2080223431已完成1 期
A Phase 1 Study of Tazemetostat in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
Tazemetostat administered orally at a dose of 800 mg twice daily (BID) was well tolerated and safe in subjects with B-cell Non-Hodgkin's lymphoma (NHL). The efficacy results suggested the antitumor response of tazemetostat.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
研究者
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