Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

Completed · Phase 2

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.

Key facts

Study ID

NCT01348490

Run by

Incyte Corporation

People needed

66

Starts

2011-06-15

Expected to finish

2018-12-19

Last updated by the study team

2020-01-28

Who can join

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

You may qualify if…

• Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
• Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
• INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
• Hemoglobin level at least 6.5 g/dL at Screening visit
• Willingness to be transfused to treat low hemoglobin levels

You may not qualify if…

• Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
• Males who cannot comply with birth control use to avoid fathering a child
• Platelet count < 50 x10\^9/L or absolute neutrophil count (ANC) < 1 x10\^9/L at the Screening visit
• Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Beverly Hills, California, United States
• Study site — Burbank, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pomona, California, United States
• Study site — San Diego, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Morristown, New Jersey, United States
• Study site — Somerville, New Jersey, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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