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Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis

NCT07750574 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-08-10

No results posted yet for this study

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.

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
  • Myelofibrosis; Anemia
  • Myelofibrosis，MF
  • Myelofibrosis (PMF)
  • Myeloid Metaplasia

Interventions

DRUG

Flonoltinib Maleate orally

Dose of Flonoltinib Maleate will be 50mg daily

DRUG

Flonoltinib Maleate orally

Dose of Flonoltinib Maleate will be 75mg daily

DRUG

Flonoltinib Maleate orally

Dose of Flonoltinib Maleate will be 100mg daily

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750574 on ClinicalTrials.gov