NCT07232290

Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension 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 extension trials.

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 extension phase: 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 extension trials.

Conditions

• Polycythemia Vera (PV)

Interventions

Type	Name	Description
DRUG	Flonoltinib 75mg	Flonoltinib Maleate Tablet 75mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
DRUG	Flonoltinib 100mg	Flonoltinib Maleate Tablet 100mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
DRUG	Flonoltinib 125mg	Flonoltinib Maleate Tablet 125mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.
DRUG	Extended Phase Dose Group	Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage

Timeline

• Start date: 2025-09-23
• Primary completion: 2027-07-30
• Completion: 2028-02-28
• First posted: 2025-11-18
• Last updated: 2026-03-04

Locations

1 site across 1 country: China