Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NS Pharma, Inc.
This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
MF patients must have received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, based on investigator assessment
≥18 years old
ECOG Performance Status of ≤ 3
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) ≥ 40 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. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ≤ 1.5 X ULN are eligible during the Phase II portion.
Absolute neutrophil count (ANC) \>1000/μL and Platelet count \> 25,000/μL
QTcB ≤ 480 msec
No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ≤ 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.
You may not be if
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
Clareo Health | Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
