Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis

ConditionsMyelofibrosis 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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorChengdu Zenitar Biomedical Technology Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Have signed the current relevant ICF prior to any study related procedures;

Understand and commit to comply with study requirements;

Be ≥18 years of age;

Be able to swallow and retain oral medications;

Disqualifiers

Have failure to recover from toxic effects of prior anticancer therapy to Grade 1 or below (except alopecia), or failure to fully recover from prior surgery (major surgery within 4 weeks);

Have known hypersensitivity to the investigational product or its excipients;

Uncontrolled diabetes with fasting blood glucose >250 mg/dL (13.9 mmol/L);

Hypertension not controlled by one or two antihypertensive drugs to the following range: systolic <160 mmHg, diastolic <100 mmHg;

Trial design

Treatments tested in this trial

Flonoltinib Maleate orally
Flonoltinib Maleate orally
Flonoltinib Maleate orally

Treatment groups

105 Participants

are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Chengdu Zenitar Biomedical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov