NCT01392443

Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF

A Multi-national Open-label Phase II Study of the JAK Inhibitor INC424 in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume was also assessed.

Conditions

• Primary Myelofibrosis (MF)
• Post-Polycythemia Vera (PV) MF
• Post-Essential Thrombocythemia (ET) MF

Interventions

Type	Name	Description
DRUG	Ruxolitinib	INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength was 5 mg/tablet INC424 phosphate (free base equivalent).

Timeline

• Start date: 2010-10-14
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2011-07-12
• Last updated: 2019-09-03
• Results posted: 2019-09-03

Locations

26 sites across 4 countries: China, Japan, South Korea, Taiwan