A Phase 1/2, Open-label, Dose-escalation, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered NS-018 in Patients with Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis
The goal of this clinical research study is to find the highest tolerable dose of NS-018 that can be given to patients with myelofibrosis. The safety of this drug will also be studied.
Treatment Location: N/A
The primary objective of the Phase 1 portion of the study is to evaluate the safety, tolerability, maximum tolerated dose (MTD), and clinically active dose of NS-018 when orally administered in patients with PMF, post-PV MF, or post-ET MF. The secondary objectives of the Phase 1 portion of the study are to determine plasma pharmacokinetics (PK), evaluate pharmacodynamic (PD) correlates, and evaluate preliminary efficacy of NS-018 in patients with PMF, post-PV MF, or post-ET MF. The primary objective of the Phase 2 portion of the study is to further evaluate the safety and efficacy of the selected dose of NS-018 in patients with PMF, post-PV MF, or post-ET MF. The secondary objectives of the Phase 2 portion of the study are to further determine plasma PK and evaluate PD correlates of NS-018 in patients with PMF, post-PV MF, or post-ET MF.
IRB Review and Approval Date: 06/02/2011
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
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