CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 222 enrolled
Drug / intervention
ruxolitinib tablets +1 moredrug
Likely dose
ruxolitinib tablets 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01243944
NCT01243944Phase 3Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Nov 19, 2010·Updated Mar 6, 2019

In Brief

A Phase 3 clinical trial evaluating ruxolitinib tablets and Best Available Therapy (BAT) for Polycythemia Vera. Completed, enrolled 222 participants across 102 sites in 18 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycythemia Vera
CountriesArgentina, Australia, Belgium, Canada, China, France, Germany, Hungary, Italy, Japan, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2010
Enrollment StartOct 27, 2010
Primary CompletionJan 15, 2014
Study CompletionFeb 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.6 years ago

Interventions

ruxolitinib tabletsdrug

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

Best Available Therapy (BAT)other

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.