An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Incyte Corporation0 个研究点目标入组 42 人开始时间: 2018年6月28日最近更新: 2021年6月21日

适应症

试验速览

暂无简介。

•Cohort A only
•Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit.
•Cohort B only
•Must have had initial reduction in spleen on ruxolitinib treatment (response is defined by any spleen length or volume reduction, by palpation or MRI/CT assessment, from baseline while on previous ruxolitinib treatment per IWG-MRT ELN 2013 guidelines):
•- Followed by documented evidence of progression in spleen length or volume OR
•- Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume.
•All subjects
•Men and women, aged 18 years or older.
•Confirmed diagnosis of PMF, PPV-MF, or PET-MF according to revised WHO 2016 criteria.
•Must have palpable spleen of = 5 cm below the left subcostal margin on physical examination at the screening visit. (If spleen is not palpable due to body habitus, spleen enlargement must be documented by other means [eg, ultrasound or MRI] and study sponsor medical monitor be contacted for acceptance).
•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 21
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 21

•All subjects
•Lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
•Previous treatment with itacitinib or JAK1 inhibitors (JAK1/JAK2 inhibitor ruxolitinib is permitted).

发起方