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

Incyte

Status and phase: Completed; Phase 2

Conditions: MPN (Myeloproliferative Neoplasms)

Treatments: Drug: Ruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348490

INCB18424-258

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Ruxolitinib 5 mg

Experimental group

Description:

Participants began administration with 5 mg ruxolitinib twice daily (BID) orally. Beginning at the Week 4 visit, doses of ruxolitinib could be increased in 5 mg once a day (QD) increments every 4 weeks every 4 weeks not to exceed a dose of 25 mg BID.

Treatment:

Drug: Ruxolitinib