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COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
Not Recruiting
Trial ID: NCT00952289
Purpose
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).
Official Title
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
Stanford Investigator(s)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
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
Exclusion Criteria:
- 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
Intervention(s):
drug: Ruxolitinib
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061