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

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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