Trial Details
Area of Research: PMF, Post-PV MF,
Post-ET MF
Phase 1/2

A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Brief Summary:

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.This is a Phase 1/2 multicenter, single arm, open-label study in Japanese subjects with DIPSS intermediate or high-risk PMF, post-PV or post-ET MF. The study consists of 2 parts: Phase 1 part to determine safety and tolerability and a RP2D. The Phase 1 portion of the study will explore one or more drug doses for fedratinib (300 mg and 400 mg) using a mTPI-2 design. Following completion of dose escalation and determination of MTD and/or a RP2D, the study will progress into the Phase 2 part to further evaluate the efficacy and safety.The study will consist of 3 periods: a Screening Period, a Treatment Period including a 30-day follow-up after last dose visit and a survival follow-up period.

For more information, please contact the recruiting sites directly.
If there is no contact information, please email: The first line of the email MUST contain the NCT # and Site #.

16 locations available.

Log In

Log in below to access your account on BMS Science or Bolder Science. If you have an existing Bolder Science account, please use your login credentials for that account here.

Don't have an account? Sign Up


Please enter your email address.

You will receive a link to create a new password via email.

Log In


Create Account

Use the form below to create one account that will be used across both BMS Science and Bolder Science. Clinical trials that you save on either site will be shown together on your dashboard on Bolder Science. If you already have an account, you can log in here.

  • 8 characters minimum
  • First character cannot be a number
  • Last character cannot be a number