NCT00509899

Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).

Detailed description

This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts: Part 1: Dose escalation and determination of maximum tolerated dose (complete). Part 2: Exploration of alternative dosing schedules (complete). Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).

Conditions

• Myelofibrosis
• Polycythemia Vera
• Thrombocytosis

Interventions

Type	Name	Description
DRUG	Ruxolitinib	5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-12-01
• Completion: 2017-02-01
• First posted: 2007-08-01
• Last updated: 2018-03-12
• Results posted: 2012-08-02

Locations

2 sites across 1 country: United States