Myeloproliferative Neoplasms Clinical Trial
Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
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).
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.
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.
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.
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There are 28 Locations for this study
Worcester Massachusetts, 01655, United States
Houston Texas, 77002, United States
Houston Texas, 77030, United States
Augsburg , 86150, Germany
Halle , 6120, Germany
Jena , 07747, Germany
Rostock , 18057, Germany
Alessandria , 15121, Italy
Brescia , 25123, Italy
Palermo , 90127, Italy
Banpo-dong , 164 K, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jinju-si , 52727, Korea, Republic of
Seongnam , 164 K, Korea, Republic of
Seoul , 4401, Korea, Republic of
Ipoh Perak, 30450, Malaysia
Ampang , 68000, Malaysia
Johor Bahru , 80100, Malaysia
Kota Bahru , 15586, Malaysia
Kota Kinabalu , 88586, Malaysia
Kuala Lumpur , 59100, Malaysia
Petaling Jaya , , Malaysia
Pulau Pinang , 10990, Malaysia
Khon Kaen , 40002, Thailand
Songkla , 90110, Thailand
Bath England, BA1 3, United Kingdom
London England, SE1 9, United Kingdom
Manchester England, M20 4, United Kingdom
Plymouth England, PL6 8, United Kingdom
West Bromwich England, B71 4, United Kingdom
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