Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07340138
Phase
PHASE1
Status
Recruiting
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Conditions

  • Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
  • Post-polycythemia Vera Myelofibrosis (Post-PV MF)
  • Primary Myelofibrosis (PMF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelabresib — DRUG
    125 mg orally once daily (QD) on Days 1-14 of each 21-day cycle
  • Ruxolitinib — DRUG
    5-25 mg twice daily (BID)

Study Details

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).

Key Dates

First listed
Jan 14, 2026
Start date
Apr 15, 2026
Status verified
Jun 2026
Primary completion
Nov 16, 2026
Completion
Dec 18, 2030

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pelabresib + Ruxolitinib
    Eligible participants will receive pelabresib 125 mg once daily (QD) in combination with ruxolitinib at doses ranging from 5 to 25 mg twice daily (BID).

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]

Central Contacts

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