Trials / Terminated
TerminatedNCT04854096
Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 Versus Best Available Therapy in Subjects With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- NS Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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 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.
Conditions
- Primary Myelofibrosis
- Post-essential Thrombocythemia Myelofibrosis
- Post-polycythemia Vera Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NS-018 | Experimental |
| DRUG | Best Available Therapy | Active Comparator |
Timeline
- Start date
- 2023-01-31
- Primary completion
- 2024-05-16
- Completion
- 2024-05-16
- First posted
- 2021-04-22
- Last updated
- 2025-05-23
- Results posted
- 2025-05-23
Locations
52 sites across 9 countries: United States, Germany, Italy, Malaysia, Poland, South Korea, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04854096. Inclusion in this directory is not an endorsement.