Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
NCT07340138 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-04-29
Summary
This Phase 1b, multicenter, open-label study aims to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of pelabresib as add-on to ruxolitinib in Japanese patients with myelofibrosis (MF).
Conditions
- Primary Myelofibrosis (PMF)
- Post-polycythemia Vera Myelofibrosis (Post-PV MF)
- Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Interventions
- DRUG
-
Pelabresib
125 mg orally once daily (QD) on Days 1-14 of each 21-day cycle
- DRUG
-
5-25 mg twice daily (BID)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2026-11-16
- Completion
- 2030-12-18
Countries
- Japan
Study Locations
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