Polycythemia Vera (PV)Phase 2NCT07232290
Phase IIa Study of Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
A Phase 2 study testing Flonoltinib 75mg, Flonoltinib 100mg and Flonoltinib 125mg in people with Polycythemia Vera (PV), run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera (PV)
- What is being tested?
- Flonoltinib 75mg, Flonoltinib 100mg and Flonoltinib 125mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 28 Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old and gender not limited when signing the informed consent form;
- Diagnosed as PV according to WHO standards (2016 edition), and resistant/intolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2);
- When screening, the peripheral blood blasts are 0%;
- Meet any of the following criteria and achieve HCT<= 45% before randomization/enrollment:
- 1)At least 2 Phlebotomy and/or apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one Phlebotomy and/or apheresis treatment has been performed within the 16 weeks and HCT>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count >= 1.0 × 10 ^ 9/L, platelet count >= 100 × 10 ^ 9/L and <= 1000 × 10 ^ 9/L; ALT and AST<= 2.5 × ULN; TBIL<=2.0×ULN; Serum creatinine <= 1.5 × ULN; 6.ECOG 0-2 points; 7.Can understand and voluntarily sign an informed consent form.
Who cannot join
- Individuals with allergies or suspected allergies to the test drug and its excipients;
- The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss, blood routine and blood biochemical indicators refer to inclusion criteria 4 and 5), or have not fully recovered from previous surgeries (having undergone major surgery within 4 weeks);
- In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present;
- Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening;
- Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders are included in the screening process;
- Patients with basic diseases that are difficult to control in combination with drug treatment during screening, including but not limited to: diabetes, hypertension , peripheral neuropathy ;
Show all 21Show fewer
- Screening for individuals who have experienced congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or require treatment for arrhythmia within the past 6 months;
- Individuals with QTcF>450 ms (male) and QTcF>470 ms (female) on electrocardiogram during screening;
- Individuals who have experienced active tuberculosis infection within the past year prior to screening, or those whose tuberculosis related test results indicate latent infection during screening;
- Patients who have undergone splenectomy or splenic radiotherapy in the past;
- When screening, any of the following situations exist: a) Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) is positive, and HBV-DNA detection is positive or above the upper limit of normal value; b) HCV antibody positive and HCV-RNA detection positive; c) Positive for anti Treponema pallidum antibody (TP Ab) and positive for Treponema pallidum non-specific antibody (PRP or TRUST) detection; d) Positive for Human Immunodeficiency Virus Antibody (HIV Ab);
- Individuals with epilepsy or mental illnesses requiring medication during screening (excluding insomnia);
- Individuals who have suffered from other malignant tumors within the past 5 years prior to the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
- Patients with congenital or acquired bleeding disorders or active thrombotic disorders during screening;
- Combining other serious diseases during screening may affect patient safety or compliance, according to researchers;
- Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea, recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks), JAK inhibitors (such as Ruxolitinib), 32P (needs to be discontinued for 8 weeks), Busulfan, etc;
- Patients who receive treatment with other clinical trial drugs or clinical trial medical devices before screening and have not fully eluted for at least 5 half lives or 1 month (whichever is longer);
- Pregnant or lactating women;
- Individuals who have the ability to conceive but refuse to use contraceptive measures during the trial period ;and within 6 months after the trial ends;
- Vaccination with active or attenuated vaccines within 4 weeks prior to screening;
- Researchers believe that there are other factors that are not suitable for participating in the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin
Qirou Wang, 022-23909095, ec@ihcams.ac.cn
About this study
Official title: An Open Label, Randomized, Parallel Controlled, Multicenter Phase IIa Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Flonoltinib Maleate Tablets in the Treatment of Hydroxyurea or Interferon Resistant/Intolerant Polycythemia Vera
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon. The study divided into two stages: dose exploration stage: three dose groups are set, with three subjects in each group, totally nine subjects in each group; Dose expansion stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose expansion stage.
Read the detailed description
The treatment goal of polycythemia vera is to avoid initial or recurrent thrombosis, control disease-related symptoms, prevent post PV MF and/or acute leukemia transformation after polycythemia vera. Almost all PV patients have non receptor type Janus kinase 2 (JAK2) gene mutations, typically JAK2 V617F. This drug is intended for patients with myeloproliferative neoplasms (MPN), mainly including moderate to high-risk myelofibrosis (FM) (including primary myelofibrosis (PMF)), post polycythemia vera myelofibrosis (PPV-MF), and post thrombocytopenia myelofibrosis (PET-MF), polycythemia vera (PV), and primary thrombocytosis (ET).
Flonoltinib Maleate (FM), a triple target inhibitor of JAK2/FLT3/CDK6, has the potential to inhibit JAK2 signaling pathway activity and treat bone marrow proliferative tumors.
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design. The plan is to recruit patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon. The study is divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group,for a total of 9 subjects; Dose expansion stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration phase, it is planned to select 2-3 dose groups for dose expansion stage.
- Conditions
- Polycythemia Vera (PV)
- Being tested
- Flonoltinib 75mg, Flonoltinib 100mg, Flonoltinib 125mg, Extended Phase Dose Group
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flonoltinib 75mgDrug
Flonoltinib Maleate Tablet 75mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
Flonoltinib 100mgDrug
Flonoltinib Maleate Tablet 100mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
Flonoltinib 125mgDrug
Flonoltinib Maleate Tablet 125mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
Extended Phase Dose GroupDrug
Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage
| Study group | Role | What they receive |
|---|---|---|
| Dose exploration stage group 1 | Experimental | Flonoltinib 75mg Receives: Drug: Flonoltinib 75mg |
| Dose exploration stage group 2 | Experimental | Flonoltinib 100mg Receives: Drug: Flonoltinib 100mg |
| Dose exploration stage group 3 | Experimental | Flonoltinib 125mg Receives: Drug: Flonoltinib 125mg |
| Expansion stage Dose Group | Experimental | Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage，2 or 3 doses of Flonoltinib will be selected，QD Receives: Drug: Extended Phase Dose Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved HCT control
Achieve HCT<45% without undergoing Phlebotomy or apheresis treatmen
Measured: At the end of the week 28
Secondary outcomes (5)
The proportion of subjects who achieved complete hematological remission
Without undergoing venous bloodletting or apheresis, achieve HCT<45%, PLT <= 400×10^9/L, and WBC<10×10^9/L
Measured: week 28 and 52
The duration of HCT control
The duration of HCT control (defined as the time elapsed from the date when HCT control was first recorded from the start of Day 29 treatment to the date when HCT increased to >= 45%)
Measured: The time elapsed from the date when HCT control was first recorded from the start of Day 29 treatment to the date when HCT increased to >= 45%
Changes in the total symptom score of MPN-SAF TSS scale
The MPN-SAF-TSS is used to assess the symptom burden of patients with myeloproliferative neoplasms. The questionnaire also reflects the quality of life of patients to a certain extent. During the diagnosis and treatment process, the MPN-10 questionnaire includes 10 sub symptoms (fatigue, early satiety, abdominal discomfort, poor activity, lack of concentration, night sweats, skin itching, bone pain, fever, and weight loss). Each item is graded from 0 (none) to 10 (heaviest), with a total score of 0-100 points. The higher the total score, the heavier the symptom burden.
Measured: week 16, 28, 40, and 52
Proportion of subjects who did not experience thrombosis or bleeding events
Proportion of subjects who did not experience thrombosis or bleeding events at the end of treatment in weeks 28 and 52
Measured: week 28 and 52
Changes in variant allele frequency to baseline
Subjects with JAK2V617F quantification>0% during the screening period will undergo JAK2V617F quantification testing at weeks 28 and 52
Measured: week 28 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start23 Sep 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia Vera (PV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Doctor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)Ting Niu, Doctor, Principal investigator, West China HospitalWei Yang, Doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232290
- Sponsor's protocol ID
- FM-PV-01
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No