NCT01243944

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)

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 (The RESPONSE Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	ruxolitinib tablets	Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
OTHER	Best Available Therapy (BAT)	Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

Timeline

• Start date: 2010-10-27
• Primary completion: 2014-01-15
• Completion: 2018-02-09
• First posted: 2010-11-19
• Last updated: 2019-03-06
• Results posted: 2015-03-06

Locations

102 sites across 18 countries: United States, Argentina, Australia, Belgium, Canada, China, France, Germany, Hungary, Italy, Japan, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom