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Spots Global Cancer Trial Database for A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis

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Trial Identification

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

Conditions

Myelofibrosis

Interventions

TG101348

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Ayalew Tefferi, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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