OncoMatch/Clinical Trials/NCT07232290
Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
Is NCT07232290 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Flonoltinib 75mg and Flonoltinib 100mg for polycythemia vera (pv).
Treatment: Flonoltinib 75mg · Flonoltinib 100mg · Flonoltinib 125mg · Extended Phase Dose Group — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hydroxyurea or interferon
resistant/intolerant to hydroxyurea or interferon treatment
Cannot have received: hydroxyurea
Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea
Cannot have received: recombinant interferon - α
Exception: long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks
Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including ... recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks)
Cannot have received: JAK inhibitor (ruxolitinib)
Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including ... JAK inhibitors (such as Ruxolitinib)
Cannot have received: radioisotope (32P)
Exception: needs to be discontinued for 8 weeks
Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including ... 32P (needs to be discontinued for 8 weeks)
Cannot have received: alkylating agent (busulfan)
Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including ... Busulfan
Lab requirements
Blood counts
neutrophil count >= 1.0 × 10^9/L, platelet count >= 100 × 10^9/L and <= 1000 × 10^9/L
Kidney function
Serum creatinine <= 1.5 × ULN
Liver function
ALT and AST <= 2.5 × ULN; TBIL <= 2.0 × ULN
Cardiac function
QTcF <= 450 ms (male), <= 470 ms (female); no congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or arrhythmia requiring treatment within past 6 months
ALT and AST<= 2.5 × ULN; TBIL<=2.0×ULN; Serum creatinine <= 1.5 × ULN; neutrophil count >= 1.0 × 10^9/L, platelet count >= 100 × 10^9/L and <= 1000 × 10^9/L; QTcF>450 ms (male) and QTcF>470 ms (female) [excluded]; 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 [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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