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Brief Title: A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis
Official Title: A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis
Study ID: NCT00631462
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Mayo Clinic, Rochester, Rochester, Minnesota, United States
MD Anderson Cancer Center, Houston, Texas, United States
Name: Ayalew Tefferi, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR