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)

Completed · Phase 3

Conditions studied: Polycythemia Vera

In brief

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).

Key facts

Study ID

NCT01243944

Run by

Incyte Corporation

People needed

222

Starts

2010-10-27

Expected to finish

2018-02-09

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Pomona, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Columbia, Maryland, United States
• Study site — Southfield, Michigan, United States
• Study site — Jefferson City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Morristown, New Jersey, United States
• Study site — Somerville, New Jersey, United States
• Study site — Charleston, South Carolina, United States
• Study site — Greenville, South Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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