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

This study is currently recruiting participants.
Verified February 2014 by Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: May 4, 2011
Last updated: February 7, 2014
Last verified: February 2014

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.

Condition Intervention Phase
Primary Myelofibrosis
Post Essential Thrombocythemia-myelofibrosis
Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF [ Time Frame: Measured at baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Establish adequate dose of INCB018424 in patients with low platelets [ Time Frame: Baseline, every four weeks through Week 24, thereafter every 12 weeks until study completion at week 156. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib (INCB018424) Drug: Ruxolitinib (INCB018424)
Ruxolitinib (INCB018424), 5 mg bid


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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 ANC < 1 x10^9/L at the Screening visit
  • Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - INR laboratory values cannot be > 1.5 x upper limit of normal at study entry.
  Contacts and Locations
Please refer to this study by its identifier: NCT01348490

Contact: Incyte Corporation Call Center 1.855.463.3463

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Sponsors and Collaborators
Incyte Corporation
Study Director: Lance Leopold, MD Incyte Corporation
  More Information

No publications provided by Incyte Corporation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Incyte Corporation Identifier: NCT01348490     History of Changes
Other Study ID Numbers: INCB18424-258
Study First Received: May 4, 2011
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia Vera
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders processed this record on April 17, 2014