JPRN-jRCT2080224158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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
Parsaclisib was shown to be safe and tolerable in Japanese participants with relapsed or refractory B-cell malignancies at parsaclisib 20 mg QD for 8 weeks followed by the same dose once weekly. Parsaclisib was not associated with significant transaminase elevations or with any new or unexpected AEs in the Japanese population. Based on preliminary analyses, the PK profile of parsaclisib in Japanese participants is comparable to the profile in the US population and no dose modifications are recommended.
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) 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.
- •2) Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
- •3) Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
- •4) 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.
- •5) Life expectancy > 3 months.
- •6) Eastern Cooperative Oncology Group performance status of 0 to 2.
- •7) Adequate hematologic, hepatic, and renal function.
排除标准
- •1) Evidence of transformed non-Hodgkin's lymphoma histologies.
- •2) Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
- •3) History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- •4) Prior treatment with idelalisib, other selective PI3K delta inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
- •5) 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.
- •6) Active graft-versus-host disease.
- •7) History of stroke or intracranial hemorrhage within 6 months of study drug administration.
- •8) 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.
- •9) Known human immunodeficiency virus infection.
- •10) Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
研究者
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