Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis

Stopped early · Phase 2

Conditions studied: Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis

In brief

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 severe thrombocytopenia (platelet count \<50,000/µL) including subjects with intermediate-2 or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPSS).

Key facts

Study ID

NCT04854096

Run by

NS Pharma, Inc.

People needed

7

Starts

2023-01-31

Expected to finish

2024-05-16

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Houston Methodist Hospital — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Hamatologisch-onkologische Praxis Heinric/Bangerter Ausgsburg GbR — Augsburg, Germany
• Universitaetsklinikum Halle (Saale) — Halle, Germany
• Universitaetsklinikum Jena — Jena, Germany
• Universitätsmedizin Rostock — Rostock, Germany
• AO SS Antonio — Alessandria, Italy
• Azienda Ospedaliera SS. Antonio — Alessandria, Italy
• ASST Spedali Civili di Brescia — Brescia, Italy
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia, Italy
• AOU "Policlinico - San Marco" — Catania, Italy
• ASST Fatebenefratelli Sacco — Milan, Italy
• Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan, Italy
• AO di Rilievo Nazionale — Naples, Italy
• AO di Rilievo Ntl A Cardarelli — Naples, Italy
• Azienda Ospedaliera di Rilievo Nazionale — Naples, Italy
• Azienda Ospedaliera di Padova — Padova, Italy
• Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone — Palermo, Italy
• Istituto Nazionale Tumori Regina Elena IRCCS — Roma, Italy
• Azienda Ospedaliera Universitaria Policlinico Umberto I — Roma, Italy
• AO Uni Policlinico Umberto I — Rome, Italy
• Hospital Raja Permaisuri Bainun — Ipoh, Perak, Malaysia
• Hospital Ampang — Ampang, Malaysia
• Hospital Sultanah Aminah — Johor Bahru, Malaysia
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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