The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)
Inclusion Criteria:
- Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
- ≥18 years old
- ECOG Performance Status of ≤2
- Estimated life expectancy of ≥12 weeks
- Male or non-pregnant, non-lactating female patients
- Serum creatinine of ≤1.5 × the upper limit of normal (ULN)OR estimated creatinine clearance (CrCl) ≥60 ml/min/1.73 m2
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × the upper limit of normal (ULN) and total bilirubin ≤1.5 × ULN
- Absolute neutrophil count (ANC) >1000/μL and Platelet count >50,000/μL
- QTcB ≤480 msec
- No MF-directed treatment for at least 2 weeks prior to initiation of NS-018
Exclusion Criteria:
- Active, uncontrolled systemic infection
- Patients with any unresolved toxicity greater than Grade 1 from previous anticancer therapy
- Potentially curative therapy is available
- Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 or taking medication known to be strong inhibitors or inducers of CYP3A4
- Patients with a serious cardiac condition within the past 6 months
- Pregnant or lactating
- Radiation therapy for splenomegaly within 6 months prior to study entry
- Splenectomy (Phase 2 portion of the study only)
- Known HIV positive status
- Known active hepatitis, a history of viral hepatitis B or hepatitis C, or known positive hepatitis B serologies without a history of immunization
Last updated: 03/21/2013
NCT ID: NCT01423851
IRB Number:11-000895
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