An Efficacy and Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Official Title

A Phase 3b, Multicentre, Single-arm, Open-label Safety AND Efficacy Study of Fedratinib in Subjects With DIPSS-Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Summary:

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in 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) and Previously Treated with Ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction of spleen volume and one of the secondary objectives is to evaluate the safety of fedratinib

Trial Description

Primary Outcome:

  • Proportion of subjects who have a ≥ 35% SVR at end of Cycle 6
Secondary Outcome:
  • Adverse Event(s)
  • Proportion of subjects who have ≥ 50% reduction in spleen size by
  • Symptom response rate (SRR)
  • To evaluate durability of spleen volume response (DR)
  • To evaluate the durability of spleen response by palpation (DRP)
  • Durability of symptoms response (DSR)
  • Gastrointestinal Adverse Events
  • Wernicke encephalopathy (WE) events
  • Wernicke encephalopathy (WE) thiamine monitoring

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society