Polycythemia Vera Clinical Trial
Official title:
A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the
treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in
PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to
hydroxyurea or have undergone treatment with interferon. In Part B, patients must be
resistant or intolerant to hydroxyurea.
This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of
KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2
different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients
will be randomized either to treatment with KRT-232 administered at the recommended dose and
schedule from Part A or to treatment with ruxolitinib.
n/a
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