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New treatment option for Polycythemia Vera (PV)
Official title Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
ClinicalTrials.gov ID: NCT07232290
What this study is testing
What is Flonoltinib 75mg?
Flonoltinib 75mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycythemia vera (pv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- When screening, the peripheral blood primitive cells are 0%;
- Meet any of the following criteria and achieve HCT\ 45% at the time of screening; 5.When screening, laboratory test indicators meet the following...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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%;
- Meet any of the following criteria and achieve 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 ×...
- 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...
- 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 ;
- 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...
- 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...
- 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 -...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.