COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
Trial ID or NCT#
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).
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
- - 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
- - Subjects with a life expectancy of less than 6 months - Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts - Subjects with inadequate liver or renal function - Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy - Subjects with an active malignancy over the previous 5 years except specific skin cancers. - Subjects with severe cardiac conditions - Subjects who have had splenic irradiation within 12 months
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Cancer Clinical Trials Office