A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis
Sumitomo Pharma America, Inc.
Summary
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
Description
Arm 1 will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive treatment with a JAK inhibitor. Arm 2 will enroll patients who are on a stable dose of ruxolitinib, but who have either lost response or had a suboptimal or plateau in response. Arm 3 will enroll patients who have been previously treated with a JAK inhibitor (except momelotinib)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Patients must meet all of the following inclusion criteria to be eligible: Nuvisertib (TP-3654) Monotherapy Arm: * Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF and intermediate or high-risk primary or secondary MF * Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor * Fulfill the following clinical laboratory parameters: * Platelet count ≥ 25 x 10\^9 /L, without assistance of growth factors or platelet transfusions * ANC ≥…
Interventions
- DrugNusivertib
Oral PIM Inhibitor
- DrugRuxolitinib
Oral JAK inhibitor
- DrugMomelotinib
Oral JAK inhibitor
Locations (84)
- University of AlabamaBirmingham, Alabama
- The University of Arizona Cancer CenterTucson, Arizona
- City of HopeDuarte, California
- University of Southern CaliforniaLos Angeles, California
- Hoag Family Cancer InstituteNewport Beach, California
- Blood Cancer CenterDenver, Colorado