|Recruiting||Polycythemia Vera||Phase III||
This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of INC424 to Best Available Therapy (BAT) in subjects with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).
- Subjects diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
- Subjects resistant to or intolerant of hydroxyurea
- Subjects with a phlebotomy requirement
- Subjects with a palpable splenomegaly ≥ 5 cm below the costal margin
- Subjects with elevated white blood cell and/or platelet counts
- Subjects with an ECOG performance status of 0, 1 or 2
- Women who are pregnant or nursing
- Subjects with inadequate liver or renal function
- Subjects with significant bacterial, fungal, parasitic, or viral infection requiring treatment
- Subjects with an active malignancy within the past 5 years, excluding specific skin cancers
- Subjects with known active hepatitis or HIV positivity
- Subjects who have previously received treatment with a JAK inhibitor
- Subjects being treated with any investigational agent
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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