Clinical Trial

Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis

Study acronym: FM-MF-02
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are: Which dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis. Participants will: Take Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis. Visit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study. Visit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy. Keep a diary of their symptoms.
Trial Details
NCT Number NCT07750574
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations, Myelofibrosis With Myeloid Metaplasia, Myelofibrosis, Post ET, Myelofibrosis, Post PV, Myelofibrosis, Primary +4 more
Enrollment 105 participants
Start Date 2026-11
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-10