Status:
COMPLETED
Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Lead Sponsor:
NS Pharma, Inc.
Conditions:
Primary Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2020
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01423851
Start Date
June 1 2011
End Date
April 22 2020
Last Update
March 9 2022
Active Locations (9)
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1
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
2
UC San Diego Moores Cancer Center
San Diego, California, United States, 92093-0698
3
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
4
Northwestern University
Chicago, Illinois, United States, 60611