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

• Adverse Event(s)
• Proportion of subjects who have ≥ 50% reduction in spleen size at end of Cycle 6
• 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