Status:
TERMINATED
Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
Lead Sponsor:
NS Pharma, Inc.
Collaborating Sponsors:
Nippon Shinyaku Co., Ltd.
Conditions:
Primary Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will enroll male and female subjects who are 18 years of age or older with Primary Myelofibrosis, post-polycythemia Vera Myelofibrosis, or post-essential Thrombocythemia Myelofibrosis with ...
Detailed Description
NS-018 will be self-administered orally at a dose of 300 mg BID. The BAT will be administered according to manufacturer's instructions and Investigator discretion. Subjects will complete study visits ...
Eligibility Criteria
Inclusion
- Primary MF, post-PVMF or post-ETMF according to the DIPSS risk categories of intermediate-2 or high-risk MF
- Average platelet count of \<50,000/µL at Screening based on 2 measurements taken on different days; both measurements must be \<50,000/µL.
- ECOG performance status ≤2.
- Life expectancy \>6 months.
- Spleen volume of at least 450 cm3 measured by MRI (or by CT for applicable subjects).
- Total Symptom Score (TSS) ≥10 on the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.
- Peripheral blast count \<10%.
- No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including JAK inhibitor, erythropoietic, thrombopoietic agent, or any use of corticosteroids for MF symptom or blood count management. Low dose corticosteroids \<10 mg/day prednisone or equivalent is allowed for non-MF purposes.
Exclusion
- Active, uncontrolled systemic infection.
- Any prior treatment with more than two JAK inhibitors.
- Previous treatment with NS-018.
- Subjects actively receiving a concurrent investigational agent.
- Subjects with any unresolved AE greater than Grade 1 other than hematological AEs from previous anticancer therapy.
- Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 (see Appendix 5) or taking medication known to be strong inhibitors or inducers of CYP3A4 (see Appendix 5).
- Radiation therapy for splenomegaly within 6 months prior to study entry (screening).
- History of splenectomy or planning to undergo splenectomy.
- Subjects with a serious cardiac condition within the past 6 months such as uncontrolled arrhythmias, myocardial infarction, angina or heart disease
- Subjects diagnosed with another malignancy within 2 years prior to an enrollment.
- Subjects who have had surgery (other than placement of vascular access and bone marrow biopsy) within 4 weeks of study entry (screening), or subjects with incomplete recovery from any prior surgical procedures.
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04854096
Start Date
January 31 2023
End Date
May 16 2024
Last Update
May 23 2025
Active Locations (52)
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1
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
2
Houston Methodist Hospital
Houston, Texas, United States, 77002
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Hamatologisch-onkologische Praxis Heinric/Bangerter Ausgsburg GbR
Augsburg, Germany, 86150