Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT03123588
Phase
PHASE2
Status
Terminated

Conditions

  • MPN (Myeloproliferative Neoplasms)

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
  • Anagrelide — DRUG
    Anagrelide administered orally at a starting dose of 1 mg BID.
  • Placebo — DRUG
    Anagrelide-placebo administered orally BID
  • Placebo — DRUG
    Ruxolitinib-placebo administered orally BID.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.

Key Dates

Start date
Nov 14, 2017
Status verified
Oct 2021
Primary completion
Aug 3, 2020
Completion
Aug 3, 2020

Study Design

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

Arms

  • Experimental: Group A : Ruxolitinib and anagrelide placebo
    Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
  • Active Comparator: Group B : Anagrelide and Ruxolitinib PLacebo
    Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.

Primary Outcome Measure

Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control [ Time Frame: 52 weeks ]

Locations (26)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Pacific Shores Medical GroupLong BeachCalifornia90813-
University of Southern CaliforniaLos AngelesCalifornia90033-
Ventura County Hematology-Oncology SpecialistsOxnardCalifornia93030-
Compassionate Cancer Care Medical GroupRiversideCalifornia92501-
Innovative Clinical Research InstituteWhittierCalifornia90603-
Bond Clinic, PAWinter HavenFlorida33880-
Tift RegionalTiftonGeorgia31794-
Edward Cancer CenterNapervilleIllinois60540-
North Shore Cancer Research Association-SkokieSkokieIllinois60076-
Southern Illinois UniversitySpringfieldIllinois62702-
Clinical Trials of SWLA LLCLake CharlesLouisiana70601-
St. Agnes HospitalBaltimoreMaryland21229-
Washington University School of MedicineSt LouisMissouri63110-
Summit Medical GroupMorristownNew Jersey07960-
Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC)New YorkNew York10032-
Montefiore Medical CenterThe BronxNew York10467-
Waverly Hem OncCaryNorth Carolina27518-
Vidant Medical CenterGreenvilleNorth Carolina27858-
Gabrail Cancer Center- Canton FacilityCantonOhio44718-
INTEGRIS Cancer Institute Proton CampusOklahoma CityOklahoma73142-
INTEGRIS Southwest Medical CenterOklahoma CityOklahoma73109-
Kaiser Permanente NorthwestPortlandOregon97227-
Geisinger - Knapper ClinicDanvillePennsylvania17822-
Prairie Lakes Health Care System Inc.WatertownSouth Dakota57201-
Renovatio ClinicalThe WoodlandsTexas77401-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic· Phoenix, AZPacific Shores Medical Group· Long Beach, CAUniversity of Southern California· Los Angeles, CAVentura County Hematology-Oncology Specialists· Oxnard, CACompassionate Cancer Care Medical Group· Riverside, CAInnovative Clinical Research Institute· Whittier, CA

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