Phase 12 Study of Oral Nuvisertib TP-3654 for Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis

What this Trial Is About

Researchers are evaluating oral Nuvisertib TP-3654, a PIM inhibitor, in a Phase 12 open-label trial for patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Nuvisertib. Participants include those who have been previously treated with JAK inhibitors, those currently on ruxolitinib with suboptimal response, and patients treated with other JAK inhibitors except momelotinib. The trial includes three treatment arms Nuvisertib alone, Nuvisertib combined with ruxolitinib, and Nuvisertib combined with momelotinib. Patients will receive oral doses with dose escalation to determine safe and effective levels. Each arm enrolls specific patient groups based on prior treatments and response. The study monitors drug effects and interactions when used alone or in combination with other JAK inhibitors. Participants will be closely monitored for dose-limiting toxicities, adverse events, spleen volume reduction, symptom improvement, and other pharmacokinetic measures. Regular assessments include symptom scoring, imaging scans for spleen size, laboratory tests, and cardiac monitoring. The study duration and follow-up extend to evaluate both safety and preliminary activity, with careful tracking of treatment effects over time.

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis