EUCTR2020-003415-98-HU进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kd Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 212
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women aged 18 years or older;
- •2. Diagnosis of PMF, PPV-MF, or PET-MF;
- •3. DIPSS risk category of intermediate-1, intermediate-2, or high;
- •4. Treated with ruxolitinib for = 3 months with a stable dose for at least the last 8 weeks prior to Day 1;
- •5. Evidence of suboptimal response to ruxolitinib
- •For the complete list of inclusion criteria please refer to the protocol, section 5.1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 136
排除标准
- •1. Prior therapy with any drug that inhibits PI3K;
- •2. Use of experimental drug therapy for MF or any other standard drug used for MF (e.g., danazol, hydroxyurea) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
- •3. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- •4. Recent history of inadequate bone marrow reserve.
- •For the complete list of exclusion criteria please refer to the protocol, section 5.2
研究者
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