The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.
SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
orally administered, once a day
Investigational Site Number 840103
La Jolla, California, United States
Investigational Site Number 840102
Stanford, California, United States
Investigational Site Number 840105
Boston, Massachusetts, United States
Investigational Site Number 840106
Ann Arbor, Michigan, United States
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
Time frame: 6 months
Clinical activity and pharmacodynamics
Time frame: 6 months
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Investigational Site Number 840104
Rochester, Minnesota, United States
Investigational Site Number 840101
Houston, Texas, United States