NCT04176198

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Detailed description

Arm 1 will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive treatment with a JAK inhibitor. Arm 2 will enroll patients who are on a stable dose of ruxolitinib, but who have either lost response or had a suboptimal or plateau in response. Arm 3 will enroll patients who have been previously treated with a JAK inhibitor (except momelotinib)

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Nusivertib	Oral PIM Inhibitor
DRUG	Ruxolitinib	Oral JAK inhibitor
DRUG	Momelotinib	Oral JAK inhibitor

Timeline

• Start date: 2019-12-16
• Primary completion: 2027-04-30
• Completion: 2030-04-30
• First posted: 2019-11-25
• Last updated: 2026-04-14

Locations

83 sites across 8 countries: United States, Australia, Belgium, Canada, France, Italy, Japan, United Kingdom

Regulatory

• FDA-regulated drug study