NCT03314922已完成1 期
A Phase 1b, Open-Label, Dose-Escalation Study for the Safety, Tolerability, and Pharmacokinetics of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.
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
- •First generation Japanese; subject was born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry.
- •Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
- •Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
- •Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
- •Life expectancy > 3 months.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Evidence of transformed non-Hodgkin's lymphoma histologies.
- •Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
- •History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- •Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
- •Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.
- •Active graft-versus-host disease.
- •History of stroke or intracranial hemorrhage within 6 months of study drug administration.
- •Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug.
- •Known human immunodeficiency virus infection.
- •Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
研究组 & 干预措施
Parsaclisib
Experimental
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to approximately 1 year
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Changes in pharmacodynamic (PD) markers of B-cell activation in plasma(Up to 24 weeks)
- Objective response rate(Up to approximately 1 year)
- Duration of response(Up to approximately 1 year)
- Progression-free survival(Up to approximately 1 year)
研究者
研究点 (6)
Loading locations...
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