The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.
TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Orally administered, once a day, for 28 days, up to 6 cycles.
UCSD Moores Cancer Center
San Diego, California, United States
Stanford Comprehensive Cancer Center
Stanford, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD
Time frame: 28 days
Pharmacokinetics and pharmacodynamics
Time frame: 28 days
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Mayo Clinic, Rochester
Rochester, Minnesota, United States
MD Anderson Cancer Center
Houston, Texas, United States