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A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Placebo
  • drug : Ruxolitinib

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria - Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group - Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 - Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea Linder
6507254047
Not Recruiting

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