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

  • Interventional
  • Not Recruiting
  • NCT01423851
Eligibility Details Visit Clinicaltrials.gov

A Phase 1/2, Open-label, Dose-Escalation Multi-center Study to Assess the Safety, Tolerability, PK and PD of Orally Administered NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF

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)

This is a Phase 1/2 study that is currently enrolling JAK2 failures into the Phase 2 portion of the study.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT01423851

IRB#IRB12-2179

Lead SponsorNS Pharma, Inc.

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting