The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths
UCSF - Division of Hematology/Oncology
San Francisco, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mt. Sinai School of Medicine
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF.
Time frame: Assessed at periodic visits
Determine plasma pharmacokinetics, evaluate pharmacodynamic correlates, and estimate renal elimination of XL019
Time frame: Assessed at periodic visits
Evaluate preliminary efficacy of XL019 as a single agent when administered orally
Time frame: Assessed at periodic visits
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