INCB 50465-801: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Parsaclisib (INCB050465)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 62
- 试验地点
- 37
- 主要终点
- To assess AEs and SAEs reported in participants receiving parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone).
研究概览
简要总结
To provide continued treatment and evaluation of safety in participants receiving parsaclisib (INCB050465) as monotherapy or in combination therapy with itacitinib (INCB039110), ruxolitinib (INCB018424), or ibrutinib., or tafasitamab (INCMOR00208; including participants who remain on tafasitamab alone).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
To assess AEs and SAEs reported in participants receiving parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone).
To assess AEs and SAEs reported in participants receiving parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone).
次要结局
未报告次要终点
研究者
Clinical Trial Information
Scientific
Incyte Corp.