NCT04172246已完成1 期
A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
BeiGene15 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年1月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 15
- 主要终点
- Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment
研究概览
简要总结
This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies.
This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenström's macroglobulinemia
- •Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
- •Meeting at least one of criteria for requiring treatment
- •Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level > 0.5 g/dL for WM participants
- •Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- •Life expectancy of > 4 months
排除标准
- •Known central nervous system involvement by lymphoma/leukemia
- •Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
- •Prior allogeneic stem cell transplant
- •Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
- •Active fungal, bacterial, and/or viral infection requiring systemic therapy
- •Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199)
- •Pregnant, lactating, or nursing women
- •Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib
Experimental
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment
时间窗: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
时间窗: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
时间窗: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
Part 2: Overall response rate as assessed by Independent Review Committee (IRC)
时间窗: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever occurs first
Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib
时间窗: Up to 29 days
Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib
时间窗: Up to 29 days
次要结局
- Part 1: Progression-free survival (PFS) as assessed by the investigator(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 1: Duration of response as assessed by the investigator(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 1: Overall response rate (ORR) as assessed by the investigator(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells(Predose up to 24 hours postdose)
- Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Progression-free survival (PFS) as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Duration of response as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- To assess the efficacy of zanubrutinib as measured by overall survival(Overall survival defined as time from start of study treatment to death due to any cause)
- Part 2: Major response rate (partial response or better) for WM as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Rate of partial response or better for CLL as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Overall response rate (ORR) by disease type as assessed by the investigator(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 1: Time to response as assessed by the investigator(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib(Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1))
- Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
- Part 2: Time to response as assessed by IRC(Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier)
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研究点 (15)
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