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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Zenitar Biomedical Technology Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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 primitive cells are 0%;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Flonoltinib 75mg
  • Flonoltinib 100mg
  • Flonoltinib 125mg
  • Extended Phase Dose Group

Treatment groups

60 Participants
are divided into 4 treatment groups