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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT01243944
Phase
PHASE3
Status
Completed

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ruxolitinib tablets — DRUG
    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.

Study Details

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 Dates

Start date
Oct 27, 2010
Status verified
Feb 2019
Primary completion
Jan 15, 2014
Completion
Feb 9, 2018

Study Design

Enrollment
222 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ruxolitinib tablets
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
  • Other: Best Available Therapy
    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.

Primary Outcome Measure

The Percentage of Participants Achieving a Primary Response at Week 32 [ Time Frame: 32 Weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-ScottsdaleArizona--
-PomonaCalifornia--
-SacramentoCalifornia--
-San DiegoCalifornia--
-BridgeportConnecticut--
-New HavenConnecticut--
-Boynton BeachFlorida--
-Fort MyersFlorida--
-JacksonvilleFlorida--
-Winter ParkFlorida--
-BoiseIdaho--
-ChicagoIllinois--
-LafayetteLouisiana--
-ScarboroughMaine--
-BaltimoreMaryland--
-ColumbiaMaryland--
-SouthfieldMichigan--
-Jefferson CityMissouri--
-St LouisMissouri--
-OmahaNebraska--
-MorristownNew Jersey--
-SomervilleNew Jersey--
-CharlestonSouth Carolina--
-GreenvilleSouth Carolina--
-NashvilleTennessee--
-HoustonTexas--
-SeattleWashington--

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