Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment-II

• Research type

  Research Study

• Full title

  A Randomized Study of the JAK Inhibitor INCB018424 Tablets Compared to Best Available Therapy in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) : (The COMFORT-II Trial)

• IRAS ID

  17731

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2009-009858-24

• ISRCTN Number

  Not Sent

• Research summary

  Current therapies for myelofibrosis (MF) have limited therapeutic effect, and most countries have no drugs approved for this indication. Certain drugs approved for other indications have been tried with limited success. No approach can be considered to be standard of care, and no treatment has been associated with an improvement of overall survival. INCB018424 is an investigational drug that is currently being developed by Incyte Corporation (the sponsor of this study) for treatment of primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) and post essential thrombocythemia myelofibrosis (PET-MF).Study INCB 18424-352 is a phase 3, randomized, open label trial which compares INCB018424 therapy to best currently available therapy as determined by the investigator for each individual participant.The main purpose of this study is to compare the effectiveness of INCB018424 to the best-available therapy in reducing spleen size and in improving MF associated symptoms. About 150 people at up to 100 centres worldwide will take part in this study. Participants will be randomized in a 2:1 ratio to receive INCB018424 or the best-available therapy. Participants are intended to continue as long as they are able to tolerate the study drug, do not have disease worsening, and are receiving clinical benefit. During the study participants will be asked to complete a number of pre-defined tests and procedures, including physical examinations, electrocardiograms (ECGs) to record the activity of the heart, bone marrow biopsies to assess disease progression, magnetic resonance imaging (MRIs) to assess spleen size and blood and urine collections. All of these tests and procedures could help improve understanding of how INCB018424 may be affecting MF.This study is now completed

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  09/H0713/36

• Date of REC Opinion

  21 Jul 2009

• REC opinion

  Further Information Favourable Opinion