NCT01493414

INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,233 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	INC424	All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.

Timeline

• Start date: 2011-08-16
• Primary completion: 2017-01-26
• Completion: 2017-01-26
• First posted: 2011-12-16
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

273 sites across 25 countries: Algeria, Argentina, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Thailand, Tunisia