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OncoMatch/Clinical Trials/NCT07232290

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

Is NCT07232290 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Flonoltinib 75mg and Flonoltinib 100mg for polycythemia vera (pv).

Phase 2RecruitingChengdu Zenitar Biomedical Technology Co., LtdNCT07232290Data as of Sep 2026Location: China

Treatment: Flonoltinib 75mg · Flonoltinib 100mg · Flonoltinib 125mg · Extended Phase Dose GroupThis 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.

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Extracted eligibility criteria

Treatments studied

Other

Flonoltinib 75mgFlonoltinib 100mgFlonoltinib 125mgExtended Phase Dose Group

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: splenectomy

Patients who have undergone splenectomy or splenic radiotherapy in the past

Cannot have received: splenic radiotherapy

Patients who have undergone splenectomy or splenic radiotherapy in the past

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

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07232290 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior splenectomy, splenic radiotherapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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