Clinical Trials

Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF

Location:

Scottsdale and Phoenix,  AZ

Trial status:

Open for Enrollment

Why is this study being done?

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)

Who is eligible to participate?

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