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

Completed · Phase 2

Conditions studied: Myelofibrosis

In brief

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).

Key facts

Study ID

NCT01340651

Run by

Incyte Corporation

People needed

41

Starts

2011-03-01

Expected to finish

2012-07-01

Last updated by the study team

2014-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Winter Park, Florida, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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