NCT01423851

Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF

A Phase 1/2, Open-label, Dose-Escalation Multi-center Study to Assess the Safety, Tolerability, PK and PD of Orally Administered NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: NS Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)

Detailed description

This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.

Conditions

• Primary Myelofibrosis
• Post-Polycythemia Vera Myelofibrosis
• Post-Essential Thrombocythemia Myelofibrosis

Interventions

Type	Name	Description
DRUG	NS-018	Treatment will be administered continuously as oral daily therapy in cycles of 4 weeks in duration (28 day treatment cycles).

Timeline

• Start date: 2011-06-01
• Primary completion: 2020-04-22
• Completion: 2020-04-22
• First posted: 2011-08-26
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

9 sites across 1 country: United States