Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:June 2011
End Date:December 19, 2018

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An Open Label Assessment of Safety and Efficacy of Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis (PPV-MF) and Post Polycythemia Vera-myelofibrosis (PET-MF) Who Have Platelet Counts of 50 x 10^9/L to 100 x 10^9/L

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms
and potential side effects in patients 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.


Inclusion Criteria:

- 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 7 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

Exclusion Criteria:

- 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.
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