Myelofibrosis(MF)

Study of ruxolitinib (INCB018424) sustained release formulation in myelofibrosis patients

Incyte Study ID:
18424-260
CT.gov ID:
NCT01340651
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myelofibrosis(MF)
    • PRODUCT
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    Mar 2011 - Jul 2012
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants 18 years of age or older.
    • Participants must be diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis (PET-MF).

    Exclusion Criteria

    • Participants with a life expectancy of less than 6 months.
    • Participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child.

    Clinical Study Locations

    Location
    Status
    Location
    Houston, TX, US, TX
    Status
    Completed
    Location
    Scottsdale, AZ, US
    Status
    Completed
    Location
    Winter Park, FL, US
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    18424-260
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    41
    Primary Outcome
    Open
    Secondary Outcome
    Open