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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NS Pharma, Inc.

Criteria

Inclusion Criteria:

• 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.

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