INC424 for Polycythemia Vera (2490)
Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care
|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).
Eligibility Criteria (must meet the following to participate in this study)
- 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
Exclusions (conditions that would prevent participation in this study)
- 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
Last UpdatedMarch 19, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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