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Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis

ConditionsMyelofibrosisMyelofibrosis Due to and Following Polycythemia VeraMyelofibrosis Transformation in Essential ThrombocythemiaMyelofibrosis With High Molecular Risk MutationsMyelofibrosis With Myeloid MetaplasiaMyelofibrosis, Post ETMyelofibrosis, Post PVMyelofibrosis, PrimaryMyelofibrosis; AnemiaMyelofibrosis，MFMyelofibrosis (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Flonoltinib Maleate orally

    Drug

    Dose of Flonoltinib Maleate will be 50mg daily

  • Flonoltinib Maleate orally

    Drug

    Dose of Flonoltinib Maleate will be 75mg daily

  • Flonoltinib Maleate orally

    Drug

    Dose of Flonoltinib Maleate will be 100mg daily

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: 35 fully evaluable patients (14 JAKi-naïve - 21 JAKi-resistant) will receive Flonoltinib 50mg dailyExperimental treatment 1 intervention
Group B: 35 participants (14 JAKi-naïve, 21 JAKi-resistant) with MF will receive Flonoltinib 75mg dailyExperimental treatment 1 intervention
Group C: 35 fully evaluable patients (14 JAKi-naïve - 21 JAKi-resistant) will receive Flonoltinib 100mg dailyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants with ≥35% reduction in spleen volume as assessed by imaging from baseline to week 24

The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume will be calculated.

Time frame
Baseline and at 24 weeks on study

Secondary outcomes

1

Percentage of participants achieving a TSS50, as measured by the MFSAF v4.0 at week 24.

Participant will use the Myelofibrosis Symptoms Assessment Form to record their symptoms before they begin study therapy. They will repeat this at week 24 on study and the results recorded of the two forms will be compared. The percentage of participants who record a 50% or more reduction in their total symptom score will be calculated.

Time frame
Baseline and at 24 weeks on study
2

Absolute mean change in TSS from baseline to weeks 12 and 24 as measured by MFSAF V4.0

Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks and 24 weeks on study. The absolute mean change in their total symptom score between the 3 timepoints is calculated.

Time frame
Baseline and at 12 weeks and 24 weeks on study
3

Absolute mean change in TSS excluding fatigue from baseline to weeks 12 and 24

Participant records their symptoms on a standard form before starting study therapy and repeats this by completing the same form after 12 weeks and 24 weeks on study excluding completion of the fatigue-related question. The absolute mean change in their total symptom score between the 3 timepoints is calculated.

Time frame
Baseline, at weeks 12 and 24 on study
4

Percentage of patients achieving SVR35 from baseline to week 12 (IRC and investigator)

The spleen volume as measured by a CT or MRI scan before study therapy commences will be compared with the spleen volume as measured at week 12 by the same method as used at baseline. The percentage of participants who show a 35% or more reduction in spleen volume will be calculated. The percentages will be calculated independently by the study Independent Reading Center and the participant's study investigator.

Time frame
Baseline and at week 12 on study.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Zenitar Biomedical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: