Status:
COMPLETED
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)
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2018
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT01243944
Start Date
October 27 2010
End Date
February 9 2018
Last Update
March 6 2019
Active Locations (102)
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1
Birmingham, Alabama, United States
2
Scottsdale, Arizona, United States
3
Pomona, California, United States
4
Sacramento, California, United States