CTIS2022-501687-18-00招募中1 期
INCB 50465-801:A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Parsaclisib (INCB050465) - INCB 50465-801
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 177
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib., Currently tolerating treatment in the parent Protocol., Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone) as determined by the investigator., Has at least stable disease, as determined by the investigator., Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements., Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol., Willingness to avoid pregnancy or fathering children based on the criteria described in Protocol section 5.1, Ability to comprehend and willingness to sign an ICF.
排除标准
- •Has been permanently discontinued from study treatment in the parent Protocol for any reason., Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including tafasitamab alone) outside a clinical study., Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol., Pregnant or breastfeeding women.
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