Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Participants 18 years of age or older.

• Participants must be diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis (PET-MF).

• Participants with myelofibrosis requiring therapy must be classified as high risk (3 or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or intermediate risk level 1 (1 prognostic factor)defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).

• Participants must have a palpable spleen measuring 5 cm or greater below the costal margin.

Exclusion Criteria:

• Participants with a life expectancy of less than 6 months.

• Participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child.

• Participants with inadequate bone marrow reserve.

• Participants with history of platelet counts < 50,000/μL, platelet transfusion(s), or an absolute neutrophil count < 500/μL in the month prior to Screening.

• Participants with inadequate liver or renal function at Screening and Baseline visits.