Myeloproliferative Neoplasms Clinical Trial

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

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 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).

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Full 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 at Screening, Day 1 and Day 15 of Cycle 1, 2, 3, 4, 5, 6 and Day 1 of every cycle thereafter. At these visits, blood/urine sampling, spleen measurements, bone marrow assessments, patient-reported outcome (PRO) assessments, and safety assessments may be performed.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 mgday prednisone or equivalent is allowed for non-MF purposes.

Exclusion Criteria:

Active, uncontrolled systemic infection.
Any prior treatment with more than one JAK inhibitor.

Subject has received prior JAK inhibitor treatment and meets one of the following criteria:

A duration of the treatment is 180 days or more.
Loss of spleen response (response defined as at least 50% decrease in spleen length by palpation; loss of response defined as >50% increase in spleen length from the best response).
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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04854096

Recruitment Status:

Recruiting

Sponsor:

NS Pharma, Inc.

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There are 15 Locations for this study

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University of Massachusetts Chan Medical School
Worcester Massachusetts, 01655, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
The Catholic University of Korea, Seoul St. Mary's Hospital
Banpo-dong , 164 K, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Gyeongsang National University Hospital
Jinju-si , 52727, Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam , 164 K, Korea, Republic of
Soon Chun Hyang Central Medical Center
Seoul , 4401, Korea, Republic of
Hospital Raja Permaisuri Bainun
Ipoh Perak, 30450, Malaysia
Hospital Ampang
Ampang , 68000, Malaysia
Hospital Sultanah Aminah
Johor Bahru , 80100, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bahru , 15586, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu , 88586, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Sunway Medical Centre
Petaling Jaya , , Malaysia
Hospital Pulau Pinang
Pulau Pinang , 10990, Malaysia
Srinagarind Hospital
Khon Kaen , 40002, Thailand
Songklanagarind Hospital
Songkla , 90110, Thailand

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04854096

Recruitment Status:

Recruiting

Sponsor:


NS Pharma, Inc.

How clear is this clinincal trial information?

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