A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis

Trial ID or NCT#

NCT00631462

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to evaluate 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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia) - At least 18 years of age. - ECOG PS 0, 1, or 2.
Exclusion Criteria:
  1. - Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. - Major surgery or radiation therapy within 28 days prior to initiation of study drug.

Investigator(s)

Jason Gotlib
Hematologist-Oncologist
Professor of Medicine (Hematology)

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Contact

Andrea Linder
6507254047