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Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

2014-07-23 21:14:00 | BioPortfolio

Summary

Male or female individuals, aged 18 years or older who have been diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) who are either resistant or refractory to, intolerant of, or in the investigator's opinion not candidates for available therapy and for whom treatment of MF is indicated may enroll. This is an open label, randomized study comparing the efficacy and safety of INCB018424 tablets versus best-available therapy, as selected by the investigator. The purpose is to compare the efficacy, safety and tolerability of INCB018424 given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelofibrosis

Intervention

Best-available oral and/or parenteral therapies, INCB018424

Location

Novartis Investigative Site
Graz
Austria

Status

Active, not recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:14:00-0400

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