NCT06619522

A Phase 2 Study of INCB57643 (BET Inhibitor) in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess INCB05643 + ruxolitinib JAKi-naive patients with myelofibrosis

Detailed description

Primary Objective: To evaluate splenic response rate by imaging after 24 weeks of treatment. Secondary Objectives: To evaluate splenic response rate by imaging after 24 weeks of treatment. To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate the overall splenic response rate and the duration of splenic response To evaluate the overall splenic response rate and the duration of splenic response To evaluate the proportion of patients who achieve both a splenic response and a ≥ 50% reduction in TSS after 24 weeks of treatment.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Given orally
DRUG	INCB57643	Given orally

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2024-10-01
• Last updated: 2025-05-22

Regulatory

• FDA-regulated drug study