Clinical Trials /

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

NCT01348490

Description:

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.

Related Conditions:
  • Myelofibrosis Transformation in Essential Thrombocythemia
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Primary Myelofibrosis
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: INCB18424-258
  • NCT ID: NCT01348490

Conditions

  • Primary Myelofibrosis
  • Post Essential Thrombocythemia-myelofibrosis
  • Post Polycythemia Vera-myelofibrosis

Interventions

DrugSynonymsArms
Ruxolitinib (INCB018424)Ruxolitinib (INCB018424)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Ruxolitinib (INCB018424)Experimental
  • Ruxolitinib (INCB018424)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF
Time Frame:Measured at baseline and Week 24
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • PMF
  • PPV-MF
  • PET-MF

Last Updated

May 12, 2017