Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

• Status: Completed
• Trial end date: 2018-02-09
• Target enrollment: 0
• Participant gender: All

Summary

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Collaborator: Novartis Pharmaceuticals
• Treatments: Anagrelide; Hydroxyurea; Lenalidomide; Pipobroman; Pomalidomide

Criteria

Inclusion Criteria:

• Participants diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria

• Participants resistant to or intolerant of hydroxyurea

• Participants with a phlebotomy requirement

• Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by MRI (or CT in applicable participants ), of greater than or equal to 450 cubic centimeters

• Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

• Women who are pregnant or nursing

• Participants with inadequate liver or renal function

• Participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment

• Participants with an active malignancy within the past 5 years, excluding specific skin cancers

• Participants with known active hepatitis or HIV positivity

• Participants who have previously received treatment with a JAK inhibitor

• Participants being treated with any investigational agent