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 mg/day prednisone or equivalent is allowed for non-MF purposes.

Exclusion Criteria:

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT04854096

Recruitment Status:

Terminated

Sponsor:

NS Pharma, Inc.

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There are 43 Locations for this study

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University of Massachusetts Chan Medical School
Worcester Massachusetts, 01655, United States
Houston Methodist Hospital
Houston Texas, 77002, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Hamatologisch-onkologische Praxis Heinric/Bangerter Ausgsburg GbR
Augsburg , 86150, Germany
Universitaetsklinikum Halle (Saale)
Halle , 6120, Germany
Universitaetsklinikum Jena
Jena , 07747, Germany
Universitätsmedizin Rostock
Rostock , 18057, Germany
AO SS Antonio
Alessandria , 15121, Italy
Azienda Ospedaliera SS. Antonio
Alessandria , 15121, Italy
ASST Spedali Civili di Brescia
Brescia , 25123, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , 25123, Italy
AOU "Policlinico - San Marco"
Catania , 95123, Italy
ASST Fatebenefratelli Sacco
Milano , 20121, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
AO di Rilievo Ntl A Cardarelli
Naples , 80131, Italy
Azienda Ospedaliera di Rilievo Nazionale
Naples , 80131, Italy
AO di Rilievo Nazionale
Napoli , 80131, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo , 90127, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma , 00144, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma , 00161, Italy
AO Uni Policlinico Umberto I
Rome , 00161, Italy
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
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz , 85-16, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Hematologiczny
Wrocław , 53-41, Poland
Srinagarind Hospital
Khon Kaen , 40002, Thailand
Songklanagarind Hospital
Songkla , 90110, Thailand
Istanbul Medipol University
Bagcilar Istanbul, 34200, Turkey
Ege Universitesi Tip Fak,
İzmir , , Turkey
Namik Kemal University Medicine School
Tekirdağ , 59100, Turkey
Karadeniz Teknik Universitesi Tip Fak,
Trabzon , 61100, Turkey
Royal United Hospitals - Bath
Bath England, BA1 3, United Kingdom
Guys Hospital
London England, SE1 9, United Kingdom
University College London Hospitals
London England, WC1E , United Kingdom
The Christie NHS Foundation Trust
Manchester England, M20 4, United Kingdom
Derriford Hospital
Plymouth England, PL6 8, United Kingdom
Sandwell & West Birmingham Hospital
West Bromwich England, B71 4, United Kingdom
Western General Hospital
Edinburgh Scotland, EH2XU, United Kingdom
Western General Hospital
Edinburgh Scotland, EH4 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT04854096

Recruitment Status:

Terminated

Sponsor:


NS Pharma, Inc.

How clear is this clinincal trial information?

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