This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Dose limiting toxicity (DLT) of PRT12396
Timeframe: Through cycle 1 (4 weeks)
Incidence and severity of Adverse events
Timeframe: Through study completion, an average of 2 years
Adverse Events Leading to Dose Modifications or Discontinuation
Timeframe: Through study completion, an average of 2 years
Maximum tolerated dose (MTD) and Recommended Dose(s) for Expansion (RDE[s]) of PRT12396
Timeframe: Through study completion, an average of 2 years
Study Contact (Please Do Not Disclose Personal Information)