KRT-232 in Subjects With PMF, Post-PV MF, or Post-ET MF Who Have Failed a JAK Inhibitor

Complete Title: A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT-232 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), or Post-Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment
Trial Phase: II/III
Investigator: Bart Scott

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study is a global, open-label Phase 2 study to determine the efficacy and safety of KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2 different doses and 3 different dosing schedules of KRT-232. In Part B of the study, patients will be treated at the recommended dose and schedule from Part A.

Keywords:
  • Myelofibrosis, Primary
  • Polycythemia
  • Thrombocythemia
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Adult
II/III
Bart Scott
RG1004669
NCT03662126
A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT-232 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), or Post-Essential Thrombocythemia MF (Post-ET-MF) who are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment
Myelofibrosis, Primary
Polycythemia
Thrombocythemia